Food and Drug Administration, HHS § 884.5320

(b) Classification. Class II (perform- including natural membrane (skin) or ance standards). synthetic. (2) Class II (special controls) for nat- § 884.5225 Abdominal decompression ural rubber latex . The guid- chamber. ance document entitled ‘‘Class II Spe- (a) Identification. An abdominal de- cial Controls Guidance Document: La- compression chamber is a hoodlike de- beling for Latex vice used to reduce pressure on the Condoms Classified Under 21 CFR pregnant patient’s abdomen for the re- 884.5300’’ will serve as the special con- lief of abdominal pain during preg- trol. See § 884.1(e) for the availability of nancy or labor. this guidance document. (b) Classification. Class III (premarket approval). [73 FR 66538, Nov. 10, 2008] (c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of § 884.5310 with spermicidal lubricant. completion of a PDP is required to be filed with the Food and Drug Adminis- (a) Identification. A condom with tration on or before December 26, 1996 spermicidal lubricant is a sheath which for any abdominal decompression completely covers the penis with a chamber that was in commercial dis- closely fitting membrane with a lubri- tribution before May 28, 1976, or that cant that contains a spermicidal agent, has, on or before December 26, 1996 nonoxynol–9. This condom is used for been found to be substantially equiva- contraceptive and prophylactic pur- lent to an abdominal decompression poses (preventing transmission of vene- chamber that was in commercial dis- real disease). tribution before May 28, 1976. Any (b) Classification. Class II (perform- other abdominal decompression cham- ance standards). ber shall have an approved PMA or a declared completed PDP in effect be- [47 FR 49022, Oct. 29, 1982] fore being placed in commercial dis- tribution. § 884.5320 Glans sheath. (a) Identification. A glans sheath de- [45 FR 12684–12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 FR 50709, Sept. vice is a sheath which covers only the 27, 1996] glans penis or part thereof and may also cover the area in the immediate § 884.5250 Cervical cap. proximity thereof, the corona and (a) Identification. A cervical cap is a frenulum, but not the entire shaft of flexible cuplike receptacle that fits the penis. It is indicated only for the over the to collect menstrual prevention of and not for flow or to aid artificial insemination. the prevention of sexually-transmitted This generic type of device is not for diseases. contraceptive use. (b) Classification. Class III (premarket (b) Classification. Class II (perform- approval). ance standards). (c) Date premarket approval application (PMA) or notice of completion of a prod- § 884.5300 Condom. uct development protocol (PDP) is re- (a) Identification. A condom is a quired. A PMA or a notice of comple- sheath which completely covers the tion of a PDP is required to be filed penis with a closely fitting membrane. with the Food and Drug Administra- The condom is used for contraceptive tion on or before September 12, 2002, for and for prophylactic purposes (pre- any glans sheath that was in commer- venting transmission of sexually trans- cial distribution before May 28, 1976, or mitted infections). The device may also that has, on or before September 12, be used to collect to aid in the 2002, been found to be substantially diagnosis of . equivalent to a glans sheath that was (b) Classification. (1) Class II (special in commercial distribution before May controls) for condoms made of mate- 28, 1976. Any other glans sheath shall rials other than natural rubber latex, have an approved PMA or declared

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