# K171093: Sterile Nitrile Patient Examination Gloves, Powderfree

- Pathway: 510(k) (Traditional)
- Applicant: Sanrea Healthcare Products Pvt, Ltd.
- Decided: Jul 19, 2017 after 98 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 K132006 (2013). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132006: Sterile Nitrile Powder Free Examination Glove (Vblu), Sterle Nitrile Powder Free Examination Glove (Ablu), Hartalega Sdn Bhd (2013) Summary page 5.

## Most influential descendants
- K180452: White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim (2018), 3 descendants of its own
- K190725: Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White (2019), 2 descendants of its own
- K220250: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs (2022), 1 descendant of its own
- K232039: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (2023), 0 descendants of its own
- K212586: Amazing+ (2022), 0 descendants of its own

## Indications for use
The Sterile Nitrile Patient Examination gloves, Powder free., Blue color, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner

Source page: https://510kreport.com/device/K171093
Methodology: https://510kreport.com/methodology