# K092617: Royal Guard

- Pathway: 510(k) (Traditional)
- Applicant: Shun Thai Rubber Gloves Industry Public Co., Ltd.
- Decided: May 20, 2010 after 267 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 K051333 (2005). 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)
- K051333: Nitrile Examination Gloves, Powder Free, Shun Thai Rubber Gloves Industry Co., Ltd. (2005) Summary page 2.

## Indications for use
This glove is disposable and intended For medical purpose that is worn 0n the examiner's hand to prevent contamination between patient and examiner, gloves use lor protection againsi chemotherapy drugs as below. Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes. Nitrile Powder Free Examination Glove Blune Green White *Carmustine (BCNU) 40.00 17.00 9.00 Cyclophosphannide (Cytoxan) > 240 > 240 > 240 Doxorubicin HCId(Adhriamycin) >240 > 240 > 240 Etoposide (Toposar) >240 > 240 > 240 Fluorouracil >240 >240 >240 Paclitaxel (Taxol) >240 > 240 > 240 *Thio-Tepa 177.00 63.00 48.00 ('isplafin >240 > 240 >240 Dacarbazine (DTIC) >240 > 240 >240 Nitrile Powder Free Examination Glove(Blue) *CAUTION: Testing showed average breakthrough time of 40.00minutes with Carmustine. Nitrite Powder Free Examination Glove(Green) *WARNING: DO NOT USE WITH CARMUTINE. Nitrile Powder Free Examination Glove(White) CAUTION: Testing showed average breakthrough time of 48.00minutes with Thio-Tepa. WARNING: DO NOT USE WITH CARMUTINE.

Source page: https://510kreport.com/device/K092617
Methodology: https://510kreport.com/methodology