# K992162: Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim

- Pathway: 510(k) (Traditional)
- Applicant: Safeskin Corp.
- Decided: Aug 30, 1999 after 66 days
- Product code: LZC (Medical Glove, Specialty)
- 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
No predicates in its family tree.
20 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Safeskin blue Nitrile Examination Glove: named in the summary without a submission number

## Most influential descendants
- K101596: Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and Kimberly-Clark Purple Nitrile Xtra Powder- (2010), 11 descendants of its own
- K102032: Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove) - 12 Sterile Pairs (2010), 8 descendants of its own
- K113423: Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove (2012), 5 descendants of its own
- K200633: Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove (2020), 4 descendants of its own
- K170686: Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs (2017), 4 descendants of its own

## Indications for use
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.

Source page: https://510kreport.com/device/K992162
Methodology: https://510kreport.com/methodology