# K992062: Safeskin Sterile Purple Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Safeskin Corp.
- Decided: Aug 25, 1999 after 68 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
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 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
- K081027: Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile) (2008), 9 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
- K160709: HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves (2016), 2 descendants of its own
- K243604: Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid (2025), 0 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.

Source page: https://510kreport.com/device/K992062
Methodology: https://510kreport.com/methodology