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Know Your Medical Gloves www.myrubbercouncil.com Contents Know Your Medical Gloves

01 02 03 04 05 Rubber Functions and Disposable Benefits Benefits Medical Limitations of Medical of Using of Using Rubber Medical Gloves Gloves Medical Gloves Gloves NR Gloves Nitrile Gloves ______Medical gloves are a form of personal protective equipment that prevent contamination of healthcare workers’ hands and help reduce transmission of pathogens when they are used appropriately along 06 07 08-09 10 11 with proper hand hygiene practices. Benefits of Using Surgical Gloves: Acceptable USFDA Labelling MDR Labelling All medical gloves are disposable, single-use items to prevent cross-contamination. The two main Polychloroprene & Synthetic Double Gloving & Quality Level (AQL) Requirements for Requirements for types of disposable medical gloves are examination gloves and surgical gloves and they are available Polyisoprene (PI) Gloves Breach Detection for Medical Gloves Medical Gloves Medical Gloves ______in various types of materials including latex, nitrile, polychloroprene and synthetic polyisoprene.

Medical gloves protect both healthcare providers and patients from the spread of infection or disease 12 13 14-15 16 17 during medical procedures and examinations. The Centers for Disease Control and Prevention Labelling Requirements Labelling Requirements Good Malaysia’s Other of International of International Manufacturing Strengths Considerations (CDC) and the Occupational Safety and Health Administration (OSHA) all stress the importance of ______ISO 11193 Standards for ISO 10282 Standards Practices (GMP) appropriate selection. In 2020 alone, an estimated 348 billion pieces of rubber gloves were _____ Examination Gloves for Surgical Gloves consumed globally with most of them for medical purposes. ______

14KNOW YOUR MEDICAL GLOVES Disposable Medical Gloves

Medical gloves are single-use items for safety reasons and the reprocessing of used disposable medical gloves for reuse is not recommended for the following reasons: Functions and Limitations Soiled used medical gloves are usually highly contaminated. Reprocessing of these gloves may of Medical Gloves not be able to completely decontaminate them, basically due to the glove design.

Used gloves may contain prions that can cause transmissible spongiform encepha lopathies Depending on the barrier effectiveness of the (TSE) which is known to be resistant to many methods of decontamination and sterilisation. A protective barrier for healthcare workers gloves used, gloves do not provide complete when handling potentially infectious protection from cross-contamination or Used gloves also contain different levels of soiled biological and chemical materials which can materials or during patient care. needle stick injuries. make cleaning and sterilisation of the reprocessed gloves difficult. Sterility can only be assured when the bioburden is below 1000cfu/unit product. Reduce the risks of hand floral migration Small defects in gloves or inappropriate from healthcare workers to patients which glove removal may transmit pathogens. In addition, certain chemicals may be released during reprocessing, which can cause adverse may cause infections, such as surgical site The defects may be developed during the irreversible chemical reactions to the gloves such as dissociation of crosslinks. infections, and vice versa. glove manufacturing process, storage, or As such, reprocessing can cause deterioration in the properties of gloves, such as tensile and prolonged use, or inappropriate handling by Reduce the risks of transmitting pathogens tear strength, resulting in reduced durability of the final products. from one patient to another patient or from users, such as donning gloves while wearing a contaminated surface to a patient by rings with sharp edges. Reprocessed gloves may also contain endotoxins from the dead bacteria found in the soiled changing the gloves worn between contacts, gloves. Depending on the conditions of use, surgical followed by hand hygiene procedures. gloves should be changed at least once every 90 minutes while examination gloves once Currently, there is no validated method available for addressing the above risks. Until such a method every 15 minutes due to the risk of perforation. is developed/established, healthcare workers are advised against the use of reprocessed medical Hand hygiene is a must before wearing gloves. and after removal of glove to ensure no contamination.

24KNOW YOUR MEDICAL GLOVES 34KNOW YOUR MEDICAL GLOVES GOOD CONFORM CLOSELY CONTAIN NO OIL RESISTANCE BARRIER TEAR TACTILE ELASTICITY TO THE HAND GOOD BARRIER PROTEINS Better resistance PROPERTIES RESISTANCE SENSITIVITY Provides good fit and PROPERTIES Suitable for use by CONFIGURATION against oils, Superior than those Better than nitrile and Surpasses all other comfort, as well as Suitable for use as healthcare workers Due to the stress toluene, petrol than of gloves of other synthetic polyisoprene gloves available in the reduces hand fatigue. medical gloves. who are allergic to relaxation properties NR or synthetic materials. gloves, among others. market place. The cuff grips well to NR proteins. of rubber and body polyisoprene. the surgical gown. heat after wearing.

PRODUCT OF ESTABLISHED ALCOHOL TECHNOLOGY RESISTANCE Easy to make and low defect rate due Better than nitrile PUNCTURE to the long history of ACCELERATOR- gloves. RESISTANCE manufacturing, less FREE NITRILE waste is generated AGAINST ROUNDED during manufacturing. GLOVES PROBE Easier to make than Benefits of Using Better than NR Benefits of Using accelerator-free gloves. Both nitrile NR gloves and are ENVIRONMENTALLY NR Gloves and NR gloves have Nitrile Gloves therefore readily FRIENDLY a similar puncture available in the Low carbon resistance against market. GOOD DURABILITY needles. footprint products, High tensile and tear biodegradable resistance properties. because NR gloves are made from plant- based materials.

ANTISTATIC LOWER COST ABILITY TO RESEAL SMALL PERFORATIONS OZONE RESISTANCE PROPERTIES Lower costs than WHEN PUNCTURED BY SHARP OBJECTS GOOD RESISTANCE THIN-FILM NITRILE GLOVES Better than NR most synthetic Provides additional barrier protection against Resistant against Suitable for clean Consumes less rubber material per glove than gloves, ozone gloves except for transmission of infectious pathogens. This polar liquids and room applications NR, with improved tactile sensitivity than regular cracking rarely occurs PVC gloves which unique property is not found in most if not all chemicals. such as handling nitrile gloves. in nitrile gloves during are not durable. non-NR gloves. semi-conductor storage. products.

44KNOW YOUR MEDICAL GLOVES 54KNOW YOUR MEDICAL GLOVES Surgical Gloves: GOOD BARRIER Benefits of Using PROPERTIES Double Gloving & Breach Detection Suitable for use as Polychloroprene Gloves medical gloves. Medical gloves are normally tested fresh under unused conditions.

Under actual use conditions, their properties may deteriorate significantly due to repeated stretching, abrasion, handling of sharp objects and exposure to different types of liquids and chemicals. CONTAIN NO GOOD SOLVENT GOOD AGEING PROTEINS GOOD ELASTICITY RESISTANCE RESISTANCE The cuff can grip Suitable for use by Solvent resistance Ageing resistance healthcare workers well to the surgical The perforation rate of medical gloves during use depends on the duration of use. against polar and against heat, ozone gown. who are allergic to non-polar solvents. and light. NR proteins. The failure rate of surgical gloves due to perforation during use can be as high as 70%.

Surgical glove perforation is one of the reasons that causes surgical site infections to patients.

Risks of contracting diseases due to injury during surgery: HIV up to 0.4%; Benefits of Using Synthetic B up to 30%; and Hepatitis C up to 10%.

Polyisoprene (PI) Gloves A study indicated that the perforation rate of surgical gloves can be reduced from as high as 47.8% for single gloving to as low as 0.4% for double gloving, i.e. the rate where both outer and inner gloves were perforated.

CONTAIN NO GOOD ELASTICITY The invasive nature of surgery with its increased exposure to blood could GOOD BARRIER PROTEINS ALCOHOL The cuff can grip lead to a high risk of transfer of pathogens. Therefore, double gloving is often PROPERTIES Suitable for use by RESISTANCE well to the surgical practised in surgical operations to enhance the needed safety. Suitable for use as healthcare workers Better than nitrile gown and the fit and medical gloves. who are allergic to gloves. feel are similar to NR proteins. NR gloves. Furthermore, in double gloving, wearing a darker colour under glove and a lighter colour outer glove will allow the user to visually detect glove breach via the strong colour contrast of the wet look mark due to liquid ingress.

64KNOW YOUR MEDICAL GLOVES 74KNOW YOUR MEDICAL GLOVES Table 1: Standards and AQL values for water-tightness of medical gloves Acceptable Quality Level (AQL) Examination Gloves Surgical Gloves Standards AQL for Inspection AQL for Inspection for Medical Gloves water-tightness Level water-tightness Level ASTM 2.5 G1 1.5 G1 EN 1.5 G1 0.65 G1 AQL is an internationally accepted quality standard for measuring the percentage of pinhole defects ISO 2.5 G1 1.5 G1 in disposable gloves (for both sterile and non-sterile), which gives an indication of the glove’s barrier performance. Table 2: Standards and AQL values for dimension and tensile properties of medical gloves Examination Gloves Surgical Gloves This is an important requirement that must be met by all glove manufacturers/exporters. Standards AQL for Physical AQL for Physical Dimension & Inspection Dimension & Inspection Tensile Properties Level Tensile Properties Level ASTM 4.0 S2 4.0 S2 A statistical method of evaluating the A high AQL number implies high tolerance EN N/A N/A N/A N/A quality of medical gloves based on the for defects and therefore poorer quality ISO 2859 standard. and vice versa. ISO 4.0 S2 4.0 S2

The number of samples drawn from a lot Process average is the percentage of for testing depending on the lot size and defective gloves found in samples drawn inspection level. from a lot. Example: Four defects in 315 samples yield a process average of 1.2%. Larger lot size and higher inspection level require a larger sample size to be The lower the process average, the better drawn for testing. the quality of production lots or batches.

The properties tested for AQL include ASTM (American), EN (European) and water tightness, dimensions and physical ISO (International) standards specify properties such as tensile strength and the AQL values for several properties elongation at break. of medical gloves as shown in Tables 1 and 2. Customers may set a lower AQL The acceptance criterion depends on the value if higher quality medical gloves are AQL number. required.

84KNOW YOUR MEDICAL GLOVES 94KNOW YOUR MEDICAL GLOVES USFDA Labelling Requirements for Medical Gloves MDR Labelling Requirements

All medical gloves intended for the US market are required to have the following for Medical Gloves information on the packaging: All medical gloves intended for the European market are required to have the following information in the packaging: Name and place of business. Gloves that contain natural rubber must have a caution statement. For example: Name or registered trade name and . For sterile gloves, the indication of its address of the manufacturer. sterile state and the sterilization method Country of origin. “Caution: This Product Contains Natural shall be informed. Sterilized powdered Rubber Latex Which May Cause Allergic For imported devices, the label, or the outer gloves must include a warning about the Reactions.” packaging, or instructions for use, shall need to minimize tissue exposure to powder Identity of products – Must be specific & also contain the name and address of the residual. common Language, labelling must be in Water extractable proteins claim must authorised representative. English with several exceptions. not be lower than 50μg/dm2, based on Indication of any special storage and/or The details strictly necessary to identify handling condition that applies. both unaged and aged test results. Net quantity of contents statement – e.g. device and contents of the packaging “100 gloves, by weight.” especially for users. For sterile gloves, the word ‘STERILE’ shall . Powder free claim must not have more be used. than 2 mg of residual or trace powder Adequate directions for Use – e.g. “single . Gloves that contain natural rubber must and debris per glove. have a prominent indication on the primary For traceability, Unique Device Identifier use only.” packaging that the gloves contain natural (UDI), batch code, ‘LOT NUMBER’, or the Expiration date: Expiration date labelling rubber and a warning that the gloves may serial number shall be used. Lot number – not compulsory but may be is voluntary. Claims must meet the elicit anaphylactic responses in individuals included. properties at the end of shelf life. These who are allergic to latex. The date by which the device shall be used, properties include barrier property; in safety, expressed as the year and month. Bar coding – FDA encourages the use of . A prominent indication of whether the glove physical properties; sterility and package bar coding. is powdered or powder-free. The control Manufacturing date shall be the packaging integrity tests; and tests to support limit of powder-free gloves as established date. labelling claims. by ISO is 2µg/glove. Indication that the device is for single use. A manufacturer’s indication of single use must be consistent across the European Community.

104KNOW YOUR MEDICAL GLOVES 114KNOW YOUR MEDICAL GLOVES Labelling Requirements of International ISO 11193 Labelling Standard for Examination Gloves Requirements of International ISO 10282 Standard for Surgical Gloves All examination gloves intended for the The words “FOR SINGLE USE” or similar countries that adopt the ISO 11193 standard words with the same effect. are required to have the following information v) Glove size. All surgical gloves intended for countries that in the packaging: The words “NON-STERILE” shall be vi) The manufacturer’s identifying adopt the ISO 10282 standard are required used for non-sterile examination gloves number for traceability such as lot to have the following information on the The name or trademark of the (“STERILE” for sterile examination gloves); number. packaging: manufacturer or supplier. vii) “Date of Manufacture” or words to The words “STERILE UNLESS THIS that effect and the year in 4 digit & PACKAGE IS OPENED OR DAMAGED” The glove material used. Inner wrap shall have information on i) month. Glove size, ii) Left and Right for left hand viii) The words “Sterile unless this The words “EXAMINATION GLOVE” (or glove and right hand glove, respectively. package is opened or damaged.” The words “TEXTURED” or “SMOOTH”, “EXAMINATION GLOVES”) or “EXAM ix) The words “For Single Use.” “PRE-POWDERED” or “POWDER FREE” GLOVE” (or “EXAM GLOVES”); Outer web shall have: x) The words “Surgical Gloves.” or words to that effect for the appropriate xi) The words “Product is made from glove finish. The words “DATE OF MANUFACTURE” or similar words with the same effect, and the i) Name or trademark of the natural rubber latex which can For powdered gloves, a caution statement year in four digits and month of manufacture; manufacturer or supplier. cause allergic reactions” or similar shall be included. For example: ii) Glove material used. words with the same effect for The words “PRODUCT IS MADE FROM iii) The words “Straight Fingers” or natural . “CAUTION: Surface powder shall be NATURAL RUBBER LATEX WHICH “Curved Fingers” or similar words removed aseptically prior to undertaking MAY CAUSE ALLERGIC REACTIONS” or with the same effect for the glove Multi-unit packaging shall also include operative procedures in order to minimise similar words with the same effect for iv) The words “TEXTURED” or “xx pairs of surgical gloves” and the risk of adverse tissue reactions.” natural rubber gloves. “SMOOTH”, “PRE-POWDERED” or instruction for storage, in addition to the “POWDER-FREE” or words to that above. The manufacturer’s identifying lot effect for the appropriate glove number; glove size. finish..

124KNOW YOUR MEDICAL GLOVES 134KNOW YOUR MEDICAL GLOVES Good Manufacturing Practices (GMP)

All medical glove manufacturers, including re-packers of bulk packed medical gloves must practise the GMP principles. These include:

Manufacturing facilities must be clean Potential cross-contamination must be and hygienic. declared. Quality makes Have procedures to prevent cross- Manufacturing records must be contamination and protect product systematically maintained and traceable. the Difference integrity. Product distribution must not impact the Manufacturing processes and operating product quality. procedures must be clearly documented. Procedure for recalling from market. Critical processes and changes must be validated. Procedure of handling complaints, including corrective actions and The manufacturing process can only preventive actions. be handled by trained personnel and training records must be maintained.

144KNOW YOUR MEDICAL GLOVES 154KNOW YOUR MEDICAL GLOVES Malaysia is the The export value of rubber products was Other Considerations RM5.44 billion in 2001 of which rubber WORLD’S LARGEST gloves constituted 58%. In 2020, the PRODUCER Medical gloves are classified as medical devices EXPORT VALUE AND EXPORTER and are highly regulated products as they may be in of rubber gloves with RM40.96 BILLION contact with highly infectious pathogens such as Ebola, 59% global market share with 86% from rubber gloves Hepatitis B and human immunodeficiency virus (HIV).

Good barrier properties are of paramount importance The glove manufacturers in to prevent the transmission of pathogens from patients Malaysia have tremendously improved PRODUCTION to healthcare workers and vice versa. PRODUCTION SPEED increased from just 3000 Improper use of medical gloves may lead to the spread EFFICIENCY gloves per hour in 1988 of infectious diseases. This includes using inferior quality via automation and innovation over to the current speed medical gloves, reprocessing and reusing medical gloves, THE LAST 30 YEARS of 45,000 gloves per hour removing and disposing used medical gloves improperly.

Labelling of medical gloves is also important to ensure REDUCTION IN PRODUCT traceability and prevent adulteration. NUMBER OF QUALITY Labelling claims must be scientifically substantiated. WORKERS has also improved tremendously from for the production of All medical glove manufacturers and distributors 1.5 to AQL 0.65 or even one million pieces of gloves must be registered and regularly audited to ensure 0.1 for certain types of was reduced from 9.7 in 2009 that only good quality medical gloves are allowed to be surgical gloves. to 1.7 in 2021 (est.) commercially distributed.

Re-packers of bulk packed medical gloves must The manufacturers have also started to embrace ensure traceability of the re-packed products and WELL-ESTABLISHED no adulteration. They must also adhere to the good INDUSTRY 4.0 manufacturing practice principles. such as integration of robotics, real time data ECO-SYSTEMS such as machine fabricators, chemical collection via remote-controlled sensors, suppliers, synthetic latex manufacturers, and Medical gloves made of different materials have digitisation, analyses, and integration of support from the Malaysian Rubber Council different performance properties. different production facilities via internet for which actively promotes and enhances the easy management, cost reduction, quality Users should use the most appropriate gloves control and maintenance. competitive advantage of the rubber glove industry. and duration for their work to reap the optimum benefits of the products.

164KNOW YOUR MEDICAL GLOVES 174KNOW YOUR MEDICAL GLOVES