The following data is part of a premarket notification filed by Shun Thai Rubber Gloves Industry Co., Ltd. with the FDA for Sterile Patient Examination Glove.
| Device ID | K892554 |
| 510k Number | K892554 |
| Device Name: | STERILE PATIENT EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | SHUN THAI RUBBER GLOVES INDUSTRY CO., LTD. 238/1 RATCHADA-PISEK ROAD HUAY-KWANG, BANGKOK 10310 Thailand, TH |
| Contact | Bobby Lin |
| Correspondent | Bobby Lin SHUN THAI RUBBER GLOVES INDUSTRY CO., LTD. 238/1 RATCHADA-PISEK ROAD HUAY-KWANG, BANGKOK 10310 Thailand, TH |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-10 |
| Decision Date | 1989-05-25 |