The following data is part of a premarket notification filed by Shun Thai Rubber Gloves Industry Co., Ltd. with the FDA for Nitrile Examination Gloves, Powder Free.
| Device ID | K051333 |
| 510k Number | K051333 |
| Device Name: | NITRILE EXAMINATION GLOVES, POWDER FREE |
| Classification | Polymer Patient Examination Glove |
| Applicant | SHUN THAI RUBBER GLOVES INDUSTRY CO., LTD. 238/1 RATCHADA-PISEK ROAD HUAY-KWANG, BANGKOK 10310 Thailand, TH |
| Contact | Anan Jetsadawisut |
| Correspondent | Anan Jetsadawisut SHUN THAI RUBBER GLOVES INDUSTRY CO., LTD. 238/1 RATCHADA-PISEK ROAD HUAY-KWANG, BANGKOK 10310 Thailand, TH |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-23 |
| Decision Date | 2005-07-22 |