# K202416: Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly Clark Corporation
- Decided: Nov 30, 2020 after 98 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: 6 generations back to K000323 (2000). 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)
- K200072: KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid, Kimberly-Clark Corporation (2020) Summary page 8.

## Indications for use
CHEMICAL CONCENTRATION STANDARD LENGTH Cabazitaxel 60 mg/1.5ml (40,000 ppm) >240 min. Capecitabine 26 mg/ml (26,000 ppm) >240 min. Carmustine 3.3 mg/ml (3,300 ppm) 47.5 min. Cisplatin 1 mg/ml (1,000 ppm) >240 min. Cyclophosphamide 20 mq/ml (20,000 ppm) >240 min. Dacarbazine 10 mg/ml (10,000 ppm) >240 min. Doxorubicin HCL 2 mq/ml (2,000 ppm) >240 min. Eribulin Mesylate 0.5 mg/ml (500 ppm) >240 min. Etoposide 20 mq/ml (20,000 ppm) >240 min. Floxuridine 100 mg/ml (100,000 ppm) >240 min. Fluorouracil 50 mq/ml (50,000 ppm) >240 min. Ifosfamide 50 mq/ml (50,000 ppm) >240 min. Lenvatinib 20 mg/ml (20,000 ppm) >240 min. Mitoxantrone 2 mg/ml (2,000 ppm) >240 min. Paclitaxel, 6 mg/ml (6,000 ppm) >240 min. Pemetrexed 25 mg/ml (25,000 ppm) >240 min. Sorafenib Tosylate 200 mg/ml (200,000 ppm) >240 min. Tamoxifen 2 mg/ml (2,000 ppm) >240 min. Thiotepa 10 mg/ml (10,000 ppm) 38.2 min. Vinblastine Sulfate 1 mg/ml (1,000 ppm) >240 min. Vincristine Sulfate 1 mg/ml (1,000 ppm) >240 min. Vinorelbine 10 mg/ml (10,000 ppm) >240 min. Fentanyl Citrate 100mcg/2mL >240 min. Simulated Gastric Acid 0.2% (w/v) NaCl in 0.7% (v/v) HCL acid >240 min. Fentanyl in Gastric Acid 50/50 mix solution >240 min. Caution: Carmustine and Thiotepa have low penetration times of 47.5 min. and 38.2 min. respectively CHEMICAL CONCENTRATION XTRA Cabazitaxel 60 mg/1.5ml (40,000 ppm) >240 min. Capecitabine 26 mg/ml (26,000 ppm) >240 min. Carmustine 3.3 mg/ml (3,300 ppm) 37.3 min. Cisplatin 1 mg/ml (1,000 ppm) >240 min. Cyclophosphamide 20 mq/ml (20,000 ppm) >240 min. Dacarbazine 10 mg/ml (10,000 ppm) >240 min. Doxorubicin HCL 2 mq/ml (2,000 ppm) >240 min. Eribulin Mesylate 0.5 mg/ml (500 ppm) >240 min. Etoposide 20 mq/ml (20,000 ppm) >240 min. Floxuridine 100 mg/ml (100,000 ppm) >240 min. Fluorouracil 50 mq/ml (50,000 ppm) >240 min. Ifosfamide 50 mq/ml (50,000 ppm) >240 min. Lenvatinib 20 mg/ml (20,000 ppm) >240 min. Mitoxantrone 2 mg/ml (2,000 ppm) >240 min. Paclitaxel, 6 mg/ml (6,000 ppm) >240 min. Pemetrexed 25 mg/ml (25,000 ppm) >240 min. Sorafenib Tosylate 200 mg/ml (200,000 ppm) >240 min. Tamoxifen 2 mg/ml (2,000 ppm) >240 min. Thiotepa 10 mg/ml (10,000 ppm) 30.1 min. Vinblastine Sulfate 1 mg/ml (1,000 ppm) >240 min. Vincristine Sulfate 1 mg/ml (1,000 ppm) >240 min. Vinorelbine 10 mg/ml (10,000 ppm) >240 min. Fentanyl Citrate 100mcg/2mL >240 min. Simulated Gastric Acid 0.2% (w/v) NaCl in 0.7% (v/v) HCL acid >240 min. Fentanyl in Gastric Acid 50/50 mix solution >240 min. Caution: Carmustine and Thiotepa have low penetration times of 37.3 min. and 30.1 min. respectively

Source page: https://510kreport.com/device/K202416
Methodology: https://510kreport.com/methodology