HEAD OFFICE USA OFFICE Malaysian Rubber Export Promotion Council Malaysian Rubber Export Promotion Council Unit No. 36-02, Level 36, Q Sentral 3516, International Court, NW, Washington DC 2A Jalan Stesen Sentral 2, KL Sentral 20008 USA 50470 Kuala Lumpur, Tel : +1 202 572 9771 / 9721 Tel : +60 3 2782 2100 Fax : +1 202 572 9787 Fax : +60 3 2782 2199 Email : [email protected] Email : [email protected] INDIA OFFICE CHINA OFFICE 907, Tulsiani Chambers Shanghai Nariman Point Mumbai-400021 Unit 1708, Hong Kong Plaza Maharashtra, India 283 Huaihai Road Central, Huangpu District Shanghai 200021, P.R. China Tel : +91 22 6221 6725 Fax : +91 22 6223 2359 Tel : +86 21 3376 7001 Email : [email protected] Fax : +86 21 3376 7002 Email : [email protected] EUROPE OFFICE Guangzhou Email : [email protected] Room 505, Block A, China Shine Plaza No. 9 Linhe Xi Road, Tianhe Guangzhou 510610, P.R. China Tel : +86 20 2205 7707 Fax : +86 20 2205 7706 Email : [email protected]

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

01 02 03 04 05 Rubber Functions and Disposable %HQH½WV %HQH½WV Medical Limitations of Medical of Using of Using Gloves Medical Gloves Gloves NR Gloves Nitrile Gloves Rubber Medical 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. %HQH½WVRI8VLQJ Surgical Gloves: Acceptable USFDA Labelling MDR Labelling Polychloroprene & Synthetic Double Gloving & Quality Level (AQL) Requirements for Requirements for All medical gloves are disposable, single-use items to prevent cross-contamination. The two main Polyisoprene (PI) Gloves Breach Detection for Medical Gloves Medical Gloves Medical Gloves types of disposable medical gloves are examination gloves and surgical gloves and they are available ______in various types of materials including , nitrile, polychloroprene and synthetic polyisoprene.

12 13 14-15 16 17 Medical gloves protect both healthcare providers and patients from the spread of infection or disease Labelling Requirements Labelling Requirements Good Malaysia’s Other during medical procedures and examinations. The Centers for Disease Control and Prevention 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 2017 alone, 233 billion pieces of rubber gloves were consumed globally Examination Gloves for Surgical Gloves ______with most of them for medical purposes.

1KNOW 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. PDNHFOHDQLQJDQGVWHULOLVDWLRQRIWKHUHSURFHVVHGJORYHVGLI½FXOW6WHULOLW\FDQRQO\EHDVVXUHG when the bioburden is below 1000cfu/unit product. 5HGXFH WKH ULVNV RI KDQG ¾RUDO PLJUDWLRQ 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 WHDUVWUHQJWKUHVXOWLQJLQUHGXFHGGXUDELOLW\RIWKH½QDOSURGXFWV 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.

2KNOW YOUR MEDICAL GLOVES 3KNOW 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 3URYLGHVJRRG½WDQG 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 %HQH½WVRI8VLQJ Better than NR %HQH½WVRI8VLQJ 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.

4KNOW YOUR MEDICAL GLOVES 5KNOW YOUR MEDICAL GLOVES Surgical Gloves: GOOD BARRIER %HQH½WVRI8VLQJ PROPERTIES Double Gloving & Breach Detection Suitable for use as Polychloroprene Gloves medical gloves. Medical gloves are normally tested fresh under unused conditions.

8QGHUDFWXDOXVHFRQGLWLRQVWKHLUSURSHUWLHVPD\GHWHULRUDWHVLJQL½FDQWO\GXHWR 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 %HQH½WVRI8VLQJ6\QWKHWLF to patients. Risks of contracting diseases due to injury during surgery: HIV up to 0.4%; Polyisoprene (PI) Gloves B up to 30%; and Hepatitis C up to 10%. 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 JRZQDQGWKH½WDQG 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.

6KNOW YOUR MEDICAL GLOVES 7KNOW 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 1.5 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.

8KNOW YOUR MEDICAL GLOVES 9KNOW YOUR MEDICAL GLOVES USFDA Labelling Requirements for Medical Gloves

All medical gloves intended for the US market are required to have the following information on the packaging: MDR Labelling Requirements for Medical Gloves

Name and place of business. Bar coding – FDA encourages the use of bar coding. All medical gloves intended for the European market are required to have the following information in the packaging: Country of origin. Gloves that contain natural rubber must have a caution statement. For example:  ,GHQWLW\RISURGXFWV°0XVWEHVSHFL½F  “Caution: This Product Contains Natural common Language, labelling must be in Name or registered trade name and  )RUWUDFHDELOLW\8QLTXH'HYLFH,GHQWL½HU Rubber Latex Which May Cause Allergic English with several exceptions. address of the manufacturer. (UDI), batch code, ‘LOT NUMBER’, or the Reactions.” serial number shall be used. Net quantity of contents statement – e.g. For imported devices, the label, or the Water extractable proteins claim must “100 gloves, by weight.” outer packaging, or instructions for use, The date by which the device shall be not be lower than 50µg/dm2, based on shall also contain the name and address used, in safety, expressed as the year and both unaged and aged test results. Adequate directions for Use – e.g. “single of the authorised representative. month. use only.” Expiration date: Expiration date labelling The details strictly necessary to identify Manufacturing date shall be the is voluntary. Claims must meet the Lot number – not compulsory but may be device and contents of the packaging packaging date. properties at the end of shelf life. These included. especially for users. properties include barrier property; Indication that the device is for single use. physical properties; sterility and package For sterile gloves, the word ‘STERILE’ A manufacturer’s indication of single use integrity tests; and tests to support shall be used. must be consistent across the European labelling claims. Community.

10KNOW YOUR MEDICAL GLOVES 11KNOW YOUR MEDICAL GLOVES Labelling Labelling Requirements of Requirements of International ISO 11193 International ISO 10282 Standard for Examination Gloves Standard for Surgical Gloves

v) The manufacturer’s identifying All examination gloves intended for the All surgical gloves intended for countries that The manufacturer’s identifying lot number for traceability such as lot countries that adopt the ISO 11193 standard adopt the ISO 10282 standard are required number; glove size. number. are required to have the following information to have the following information on the vi) “Date of Manufacture” or words to in the packaging: The words “FOR SINGLE USE” or similar packaging: that effect and the year in 4 digit & words with the same effect. month. The name or trademark of the Inner wrap shall have information on i) vii) The words “Sterile unless this manufacturer or supplier. The words “NON-STERILE” shall be used for non-sterile examination gloves Glove size, ii) Left and Right for left hand package is opened or damaged.” (“STERILE” for sterile examination gloves); glove and right hand glove, respectively. viii) The words “For Single Use.” The glove material used. ix) The words “Surgical Gloves.” The words “EXAMINATION GLOVE” (or Outer web shall have: x) The words “Product is made from The words “TEXTURED” or “SMOOTH”, “EXAMINATION GLOVES”) or “EXAM natural rubber latex which can “PRE-POWDERED” or “POWDER FREE” GLOVE” (or “EXAM GLOVES”); i) Name or trademark of the cause allergic reactions” or similar or words to that effect for the appropriate manufacturer or supplier. words with the same effect for JORYH½QLVK The words “DATE OF MANUFACTURE” or ii) Glove material used. natural . similar words with the same effect, and the iii) The words “Straight Fingers” or For powdered gloves, a caution statement year in four digits and month of manufacture; “Curved Fingers” or similar words Multi-unit packaging shall also include shall be included. For example: with the same effect for the glove. The words “PRODUCT IS MADE FROM “xx pairs of surgical gloves” and iv) Glove size. instruction for storage, in addition to the “CAUTION: Surface powder shall be NATURAL RUBBER LATEX WHICH above. removed aseptically prior to undertaking MAY CAUSE ALLERGIC REACTIONS” or operative procedures in order to minimise similar words with the same effect for the risk of adverse tissue reactions.” natural rubber gloves.

12KNOW YOUR MEDICAL GLOVES 13KNOW YOUR MEDICAL GLOVES Good Manufacturing Practices (GMP)

All 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.

14KNOW YOUR MEDICAL GLOVES 15KNOW YOUR MEDICAL GLOVES Malaysia is the The export value of rubber products was Other Considerations WORLD’S LARGEST RM5.44 billion in 2001 of which rubber gloves constituted 58%. In 2017, the PRODUCER  0HGLFDO JORYHV DUH FODVVL½HG DV PHGLFDO GHYLFHV AND EXPORTER EXPORT VALUE and are highly regulated products as they may be in of rubber gloves with a RM21.65 BILLION contact with highly infectious pathogens such as Ebola, 64% global market share with 73% from rubber gloves +HSDWLWLV%DQGKXPDQLPPXQRGH½FLHQF\YLUXV +,9 

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 of infectious diseases. This includes using inferior quality via automation and innovation over 1988 to 45,000 medical gloves, reprocessing and reusing medical gloves, THE LAST 30 YEARS per hour in 2013 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  /DEHOOLQJFODLPVPXVWEHVFLHQWL½FDOO\VXEVWDQWLDWHG 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 must be registered and regularly audited to ensure 0.1 for certain types of gloves was reduced from that only good quality medical gloves are allowed to be surgical gloves. 9.7 in 2009 to 3.6 in 2016. 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 Export different performance properties. different production facilities via internet for Promotion Council which actively promotes easy management, cost reduction, quality and enhances the competitive advantage of the Users should use the most appropriate gloves control and maintenance. rubber glove industry. and duration for their work to reap the RSWLPXPEHQH½WVRIWKHSURGXFWV

16KNOW YOUR MEDICAL GLOVES 17KNOW YOUR MEDICAL GLOVES