# K211003: SHOWA (R) Blue Nitrile Powder Free Medical Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Showa Best Glove, Inc.
- Decided: Jan 19, 2022 after 292 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 K200581 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200581: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue), Hartalega NGC Sdn. Bhd. (2020) Summary page 6.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hands or fingers to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs. Chemotherapy Drug and concentration — Minimum Breakthrough, detection time in minutes: 1) Blenoxane (15.0 mg/ml) 15,000 ppm — >240 minutes 2) Busulfan (6.0 mg/ml) 6,000 ppm — >240 minutes 3) Carboplatin (10.0 mg/ml) 10,000 ppm — >240 minutes 4) Carmustine (3.3 mg/ml) 3,300 ppm — 73.7 minutes 5) Cisplatin (1.0 mg/ml) 1,000 ppm — >240 minutes 6) Cyclophosphamide (20.0 mg/ml) 20,000 ppm — >240 minutes 7) Cytarabine (100.0 mg/ml) 100,000 ppm — >240 minutes 8) Dacarbazine (10.0 mg/ml) 10,000 ppm — >240 minutes 9) Daunorubicin HCl (5.0 mg/ml) 5,000 ppm — >240 minutes 10) Docetaxel (10.0 mg/ml) 10,000 ppm — >240 minutes 11) Doxorubicin HCl (2.0 mg/ml) 2,000 ppm — >240 minutes 12) Epirubicin HCl (2.0 mg/ml) 2,000 ppm — >240 minutes 13) Etoposide (20.0 mg/ml) 20,000 ppm — >240 minutes 14) Fludarabine (25.0 mg/ml) 25,000 ppm — >240 minutes 15) Fluorouracil (50.0 mg/ml) 50,000 ppm — >240 minutes 16) Gemcitabine (38.0 mg/ml) 38,000 ppm — >240 minutes 17) Idarubicin HCl (1.0 mg/ml) 1,000 ppm — >240 minutes 18) Ifosfamide (50.0 mg/ml) 50,000 ppm — >240 minutes 19) Irinotecan (20.0 mg/ml) 20,000 ppm — >240 minutes 20) Mechlorethamine HCl (1.0 mg/ml) 1,000 ppm — >240 minutes 21) Melphalan (5.0 mg/ml) 5,000 ppm — >240 minutes 22) Methotrexate (25.0 mg/ml) 25,000 ppm — >240 minutes 23) Mitomycin C (0.5 mg/ml) 500 ppm — >240 minutes 24) Mitoxantrone (2.0 mg/ml) 2,000 ppm — >240 minutes 25) Paclitaxel (6.0 mg/ml) 6,000 ppm — >240 minutes 26) Rituximab (10.0 mg/ml) 10,000 ppm — >240 minutes 27) ThioTepa (10.0 mg/ml) 10,000 ppm — 25.4 minutes 28) Trisenox (1.0 mg/ml) 1,000 ppm — >240 minutes 29) Vincristine Sulfate (1.0 mg/ml) 1,000 ppm — >240 minutes The maximum testing time is 240 minutes. Warning: Do not use with Carmustine or ThioTepa.

Source page: https://510kreport.com/device/K211003
Methodology: https://510kreport.com/methodology