The following data is part of a premarket notification filed by Beauty Thai Rubber Chemical Co., Ltd. with the FDA for Patient Examination Glove (latex).
| Device ID | K891669 |
| 510k Number | K891669 |
| Device Name: | PATIENT EXAMINATION GLOVE (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | BEAUTY THAI RUBBER CHEMICAL CO., LTD. 29/1 MOO 3 SOI 76 SUKSAWASDI ROAD Phrapradang, Samudprakarn, TH |
| Contact | Kolkijkriengkrai |
| Correspondent | Kolkijkriengkrai BEAUTY THAI RUBBER CHEMICAL CO., LTD. 29/1 MOO 3 SOI 76 SUKSAWASDI ROAD Phrapradang, Samudprakarn, TH |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-20 |
| Decision Date | 1989-09-13 |