# K221626: Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate

- Pathway: 510(k) (Abbreviated)
- Applicant: Jr Engineering & Medical Technologies (M) Sdn. Bhd.
- Decided: Dec 7, 2022 after 184 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: 7 generations back to K042805 (2004). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202622: Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate, O&M Halyard, Inc. (2021) Summary page 5.

## Indications for use
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is a disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs. The tested chemotherapy drugs and their breakthrough detection times are as follows: Bendamustine (5 mg/ml) >240 Minutes Bleomycin (15 mg/ml) >240 Minutes Busulfan (6 mg/ml) >240 Minutes Carfilzomib (2 mg/ml) >240 Minutes Cetuximab (2 mg/ml) >240 Minutes Cladribine (1 mg/ml) >240 Minutes Cytarabine (100 mg/ml) >240 Minutes Daunorubicin HCl (5 mg/ml) >240 Minutes Decitabine (5 mg/ml) >240 Minutes Docetaxel (10 mg/ml) >240 Minutes Epirubicin HCl (2 mg/ml) >240 Minutes Fludarabine (25 mg/ml) >240 Minutes Fulvestrant (50 mg/ml) >240 Minutes Gemcitabine (38 mg/ml) >240 Minutes Idarubicin HCl (1 mg/ml) >240 Minutes Irinotecan (20 mg/ml) >240 Minutes Mechlorethamine (1 mg/ml) >240 Minutes Melphalan (5 mg/ml) >240 Minutes Oxaliplatin (5 mg/ml) >240 Minutes Paraplatin (10 mg/ml) >240 Minutes Pemetrexed (25 mg/ml) >240 Minutes Raltitrexed (0.5 mg/ml) >240 Minutes Rituximab (10 mg/ml) >240 Minutes Topotecan (1 mg/ml) >240 Minutes Triclosan (2 mg/ml) >240 Minutes Trisenox (1 mg/ml) >240 Minutes Velcade (Bortezomib) (1 mg/ml) >240 Minutes Vidaza (Azacytidine) (25 mg/ml) >240 Minutes Vinblastine (1 mg/ml) >240 Minutes Vinorelbine (10 mg/ml) >240 Minutes Carmustine (BCNU) (3.3 mg/ml) 35.0 Minutes Carboplatin (10 mg/ml) >240 Minutes Cisplatin (1 mg/ml) >240 Minutes Cyclophosphamide (Cytoxan) (20 mg/ml) >240 Minutes Dacarbazine (10.0 mg/ml) >240 Minutes Doxorubicin HCl (2 mg/ml) >240 Minutes Etoposide (20 mg/ml) >240 Minutes Fluorouracil (50 mg/ml) >240 Minutes Ifosfamide (50 mg/ml) >240 Minutes Methotrexate (25 mg/ml) >240 Minutes Mitomycin C (0.5 mg/ml) >240 Minutes Mitoxantrone (2 mg/ml) >240 Minutes Paclitaxel (6 mg/ml) >240 Minutes Thiotepa (10 mg/ml) 64.9 Minutes Vincristine Sulfate (1 mg/ml) >240 Minutes The following hazardous drugs (opioid) and concentration had no breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2ml) Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 35.0 Minutes Thiotepa (10 mg/ml) 64.9 Minutes Warning: Do not use with Carmustine or Thiotepa.

Source page: https://510kreport.com/device/K221626
Methodology: https://510kreport.com/methodology