# K990186: Synthetic Powder-Free Nitrile Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Intco. Plastic & Rubber Products Co., Ltd.
- Decided: Jun 21, 1999 after 152 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: 1 generation back to K981878 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982218: Nitrile Powder-Free Uniseal Gloves, American Healthcare Products (M) Sdn Bhd (1998) Summary page 1.
- K981878: Powderfree Nitrile Examination Gloves (Polymer Coated), Besglove Medicare Sdn. Bhd. (1998) Summary page 1.
- (no number) Ansell Edmont Powderfree Nitrile Patient Examination Gloves: named in the summary without a submission number
- (no number) American Healthcare Patient Examination Gloves: named in the summary without a submission number

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K990186
Methodology: https://510kreport.com/methodology