# K022095: Duraclean with Lycra Powder Free Polyurethane Medical Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Wilshire Technologies
- Decided: Aug 9, 2002 after 43 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K905109 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991615: Polyurethane Powder Free Dental Examination Glove, Polyurethane Powder Free Medical Examination Glove, Maxxim Medical (1999) Summary page 1.
- K010297: Sensicare Synthetic Powder Free Surgical Gloves (Poly Isoprene), Maxxim Medical (2001)
- K011198: Senicare Advantix Powder Free Polyurethane Medical Examination Glove, Sensicare Advantix Powder Free Polyurethane Dental, Maxxim Medical, Inc. (2001)
- K950033: Polyderm, Wilshire Technologies (1995) Summary page 1.
- K011482: Dermasafe Chemo Plus Powder Free Neoprene Examination Glove (Tested for Use with Chemotherapy Drugs), Wrp Asia Pacific Sdn. Bhd. (2001)
- K012048: Powder Free Neoprene Examination Gloves, Non Sterile, Wrp Asia Pacific Sdn. Bhd. (2001)
- K020317: Non-Sterile Powder Free Green Barrier-Pro Synthetic Butadiene Copolymer Examination Glove, Color: Blue, Sgmp Co., Ltd. (2002)
- K955464: Tactylon Powder Free Examination Glove, Tactyl Technologies, Inc. (1996) Summary page 1.

## Indications for use
DuraCLEANB with LYCRA @ Medical Examination Glove is a disposable device made of synthetic LYCRAB polymer that is intended for medical purposes to be worn on the examiner's hand to provide a barrier against potentially infectious materials and other contaminants.

Source page: https://510kreport.com/device/K022095
Methodology: https://510kreport.com/methodology