# K220825: Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves

- Pathway: 510(k) (Abbreviated)
- Applicant: American Nitrile Operations, LLC
- Decided: Jul 8, 2022 after 109 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K090194 (2009). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200150: Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl), Medline Industries, Inc. (2020) Summary page 5.

## Recalls of this device
- Aug 14, 2026 · Class II · Z-3291-2026: Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cro
- Aug 14, 2026 · Class II · Z-3289-2026: Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cro
- Aug 14, 2026 · Class II · Z-3290-2026: Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cro
- May 13, 2024 · Class II · Z-2320-2024: Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating on

## Indications for use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. The list of Fentanyl and Chemotherapy Drugs tested (with breakthrough times) are: Chemotherapy Drug and Concentration Breakthrough Time (minutes) Carmustine (BNCU) (3.3 mg/ml) 25.5 Cyclophosphamide (20.0 mg/ml) >240 Doxorubicin HCl (2.0 mg/ml) >240 Etoposide (20.0 mg/ml) >240 5-Fluorouracil (50.0 mg/ml) >240 Methotrexate (25.0 mg/ml) >240 Paclitaxel (6.0 mg/ml) >240 Thiotepa (10.0 mg/ml) 47.7 Vincristine Sulfate (1.0 mg/ml) >240 Fentanyl (100mcg/2ml) >240 CAUTION: Testing showed an average breakthrough time of 25.5 min for Carmustine and 47.7 min for Thiotepa.

Source page: https://510kreport.com/device/K220825
Methodology: https://510kreport.com/methodology