# K120336: Nitrile Powder Free Examination Gloves (Vio) Tested for Use with Chenitrile Powder Free Examination (Ablu) Tested for U

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega Sdn Bhd
- Decided: Jun 25, 2012 after 143 days
- Product code: LZC (Medical Glove, Specialty)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Nitrile Powder Free Examination Gloves (White) Tested for Use with Chemotherapy Drugs is a non - sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested -to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) as per below: 1. Carmustine (3.3 mg/ml) — 30.2 2. Cisplatin (1.0 mg/ml) — > 240 3. Cyclophosphamide (Cytoxan) (20.0 mg/ml) — > 240 4. Dacarbazine (10.0 mg/ml) — > 240 5. Doxorubixin Hydrochloride (2.0 mg/ml) — > 240 6. Etoposide (Toposar) (20.0 mg/ml) — > 240 7. Fluorouracil (50.0 mg/ml) — > 240 8. Methotrexate (25.0 mg/ml) — > 240 9. Mitomycin C (0.5 mg/ml) — > 240 10. Paclitaxel (6.0 mg/ml) — > 240 11. Thiotepa (10.0 mg/ml) — > 240 12. Vincristine Sulfate (1.0 mg/ml) — > 240 Please note that the following drugs have extremely low permeation times of 30.2 minutes with Carmustine (3.3 mg/ml) The Nitrile Powder Free Examination Gloves (VBLU - Violet Blue) Tested for Use with Chemotherapy Drugs is a non - sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) as per below: 1. Carmustine (3.3 mg/ml) — 30.3 2. Cisplatin (1.0 mg/ml) — > 240 3. Cyclophosphamide (Cytoxan) (20.0 mg/ml) — > 240 4. Dacarbazine (10.0 mg/ml) — > 240 5. Doxorubixin Hydrochloride (2.0 mg/ml) — > 240 6. Etoposide (Toposar) (20.0 mg/ml) — > 240 7. Fluorouracil (50.0 mg/ml) — > 240 8. Methotrexate (25.0 mg/ml) — > 240 9. Mitomycin C (0.5 mg/ml) — > 240 10. Paclitaxel (6.0 mg/ml) — > 240 11. Thiotepa (10.0 mg/ml) — > 240 12. Vincristine Sulfate (1.0 mg/ml) — > 240 Please note that the following drugs have extremely low permeation times of 30.3 minutes with Carmustine (3.3 mg/ml) The Nitrile Powder Free Examination Gloves (ABLU - Aqua Blue) Tested for Use with Chemotherapy Drugs is a non - sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) as per below: 1. Carmustine (3.3 mg/ml) — 30.4 2. Cisplatin (1.0 mg/ml) — > 240 3. Cyclophosphamide (Cytoxan) (20.0 mg/ml) — > 240 4. Dacarbazine (10.0 mg/ml) — > 240 5. Doxomubixin Hydrochloride (2.0 mg/ml) — > 240 6. Etoposide (Toposar) (20.0 mg/ml) — > 240 7. Fluorouracil (50.0 mg/ml) — > 240 8. Methotrexate (25.0 mg/ml) — > 240 9. Mitomycin C (0.5 mg/ml) — > 240 10. Paclitaxel (6.0 mg/ml) — > 240 11. Thiotepa (10.0 mg/ml) — 15.6 12. Vincristine Sulfate (1.0 mg/ml) — > 240 Please note that the following drugs have extremely low permeation times of 30.4 minutes with Carmustine (3.3 mg/ml) and 15.6 minutes with Thiotepa (10.0 mg/ml) The Nitrile Powder Free Examination Gloves (VIO - Violet) Tested for Use with Chemotherapy Drugs is a non - sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) as per below: 1. Carmustine (3.3 mg/ml) — 0.6 2. Cisplatin (1.0 mg/ml) — > 240 3. Cyclophosphamide (Cytoxan) (20.0 mg/ml) — > 240 4. Dacarbazine (10.0 mg/ml) — > 240 5. Doxorubixin Hydrochloride (2.0 mg/ml) — > 240 6. Etoposide (Toposar) (20.0 mg/ml) — > 240 7. Fluorouracil (50.0 mg/ml) — > 240 8. Methotrexate (25.0 mg/ml) — > 240 9. Mitomycin C (0.5 mg/ml) — > 240 10. Paclitaxel (6.0 mg/ml) — > 240 11. Thiotepa (10.0 mg/ml) — 46.7 12. Vincristine Sulfate (1.0 mg/ml) — > 240 Please note that the following drugs have extremely low permeation times of 0.6 minutes with Carmustine (3.3 mg/ml) and 46.7 minutes with Thiotepa (10.0 mg/ml)

Source page: https://510kreport.com/device/K120336
Methodology: https://510kreport.com/methodology