# K132006: Sterile Nitrile Powder Free Examination Glove (Vblu), Sterle Nitrile Powder Free Examination Glove (Ablu)

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega Sdn Bhd
- Decided: Nov 7, 2013 after 129 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.
6 later devices descend from it; 1 cites 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K171093: Sterile Nitrile Patient Examination Gloves, Powderfree (2017), 5 descendants of its own
- 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

Source page: https://510kreport.com/device/K132006
Methodology: https://510kreport.com/methodology