# K091652: Nitrile Powder Fre Examination Gloves (Blue) Tested for Use with Chemothreapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega Sdn Bhd
- Decided: Sep 4, 2009 after 87 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K133949: Powder Free Nitrile Patient Examination Glove,Blue and Orange Colored,Non-Sterile Tested for Use with Chemotherapy Drugs (2014), 0 descendants of its own
- K121506: Utb Blue Powder Free Nitrile (2012), 0 descendants of its own

## Indications for use
The nitrile examination gloves (Tested for use with Chemotheraphy Drugs) is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.The list of chemotheraphy drugs tested (with breakthrough times) are as below: Chemotheraphy Drugs — Breakthrough Time (Minutes) 1. Carmustine — 6.60 2. Cisplatin — > 240 3. Cyclophosphamide (Cytoxan) — > 240 4. Dacarbazine — > 240 5. Doxorubicin Hydrochloride — > 240 6. Etoposide — > 240 7. Fluorouracil — > 240 8. Methotrexate — > 240 9. Mitomycin — > 240 10. Paclitaxel — > 240 11. Thiotepa — 14.83 12. Vincristine Sulfate — > 240 "WARNING: Do not use with Carmustine and Thiotepa." The nitrile examination gloves (Tested for use with Chemotheraphy Drugs) is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The list of chemotheraphy drugs tested (with breakthrough times) are as below: Chemotheraphy Drugs — Breakthrough Time (Minutes) 1. Carmustine — 35.80 2. Cisplatin — > 240 3. Cyclophosphamide (Cytoxan) — > 240 4. Dacarbazine — > 240 5. Doxorubicin Hydrochloride — > 240 6. Etoposide — > 240 7. Fluorouracil — > 240 8. Methotrexate — > 240 9. Mitomycin — > 240 10. Paclitaxel — > 240 11. Thiotepa — 85.48 12. Vincristine Sulfate — > 240 "CAUTION: Testing showed an average breakthrough time of 35.80 minutes with Carmustine." The nitrile examination gloves (Tested for use with Chemotheraphy Drugs) is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The list of chemotheraphy drugs tested (with breakthrough times) are as below: Chemotheraphy Drugs — Breakthrough Time (Minutes) 1. Carmustine — 2.38 2. Cisplatin — > 240 3. Cyclophosphamide (Cytoxan) — > 240 4. Dacarbazine — > 240 5. Doxorubicin Hydrochloride — > 240 6. Etoposide — > 240 7. Fluorouracil — > 240 8. Methotrexate — > 240 9. Mitomycin — > 240 10. Paclitaxel — > 240 11. Thiotepa — 63.81 12. Vincristine Sulfate — > 240 "WARNING: Do not use with Carmustine."

Source page: https://510kreport.com/device/K091652
Methodology: https://510kreport.com/methodology