# K021536: Dermagrip and Multiple Powder Free Latex Examination Gloves, Non-Sterile with Protein Content Labeling Claim (50 Microgr

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Specialty Products Sdn. Bhd.
- Decided: Jun 10, 2002 after 31 days
- Product code: LYY (Latex 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Class I patient examination gloves, 80LYY, powder free: named in the summary without a submission number

## Indications for use
The patient examination glove is a disposable device and is made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The patient examination glove may also provides additional protection in other areas where users are handling certain hazardous chemical such as commonly used chemotherapy drugs, as penetration and permeation by these drugs are resisted.

Source page: https://510kreport.com/device/K021536
Methodology: https://510kreport.com/methodology