# K101436: Pearlescent Powder Free Nitrile Examination Glove with Aloe Vera (Yellow, Red, Green, Black, Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Shen Wei (Usa), Inc.
- Decided: Nov 17, 2010 after 177 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
Longest line of descent: 1 generation back to K032024 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092411: Pearlescent Powder Free Nitrile Examination Gloves with Aloe Vera (Yellow, Red, Green, Black, Blue), Shen Wei (Usa), Inc. (2009) Summary page 1.
- K032024: Powder-Free Nitrile Examination Gloves, Blue Color (Tested for  Use with Chemotherapy Drugs), Shen Wei (Usa), Inc. (2003) Summary page 3.

## Indications for use
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophosphamide, Carmustine, Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin) Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes. The following chemicals have been tested with these gloves. Cyclophosphamide >240 Doxorubicin HCl (Adriamycin) >240 *Carmustine 2.10 Etoposide >240 Fluorouracil (Adrucil) >240 Paclitaxel (Taxol) >240 *ThioTEPA 27.17 Dacarbazine >240 Cisplatin >240 Please note that the following drugs have extremely low permeation times of less than 30 minutes, Carmustine has an average breakthrough time of 2.10 minutes. Thiotepa has an average breakthrough time of 27.17 minutes. A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophospharnide, Carmustine, Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin) Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes. The following chemicals have been tested with these gloves. Cyclophosphamide >240 Doxorubicin HC1 (Adriamycin) >240 *Carmustine 0.68 Etoposide >240 Fluorouracil (Adrucil) >240 Paclitaxel (Taxol) >240 *ThioTEPA 34.21 Dacarbazine >240 Cisplatin >240 Please note that the following drug have extremely low permeation times of less than 30 minutes, Carmustine has an average breakthrough time of 0.68 minutes. Please note that the following drug have extremely low permeation times of less than 60 minutes, Thiotepa has an average breakthrough time of 34.21 minutes.

Source page: https://510kreport.com/device/K101436
Methodology: https://510kreport.com/methodology