# K972615: Chemo Plus Powder Free Blue Latex Examination Gloves (Protein Content Labeling)

- Pathway: 510(k) (Traditional)
- Applicant: Wembley Rubber Products (M) Sdn Bhd
- Decided: Jan 26, 1999 after 561 days
- Product code: LYY (Latex Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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) Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91: named in the summary without a submission number

## Most influential descendants
- K083409: Powder Free Blue Latex Patient Examination Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label (2009), 3 descendants of its own
- K121926: Blue, Latex Powder Free Examination Gloves, Tested for Use with Chemotherapy Drugs with Protein Labling Claim (50UG/DM (2012), 1 descendant of its own
- K221157: JR Medic (2022), 0 descendants of its own
- K123819: Multiple Name (2013), 0 descendants of its own

## Recalls of this device
- Jan 7, 2021 · Class II · Z-1080-2021: Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
- Jan 7, 2021 · Class II · Z-1082-2021: Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
- Jan 7, 2021 · Class II · Z-1083-2021: Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.

## Indications for use
The chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between examiner and chemotherapy agents.

Source page: https://510kreport.com/device/K972615
Methodology: https://510kreport.com/methodology