The following data is part of a premarket notification filed by Thai Medical Latex Glove Co., Ltd. with the FDA for Patient Examination Gloves (latex).
| Device ID | K892555 |
| 510k Number | K892555 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | THAI MEDICAL LATEX GLOVE CO., LTD. 64/87 TIVANON ROAD, TALAD KWAN NONTHABURI 11000 Thailand, TH |
| Contact | Prasasn Swasdi-ampai |
| Correspondent | Prasasn Swasdi-ampai THAI MEDICAL LATEX GLOVE CO., LTD. 64/87 TIVANON ROAD, TALAD KWAN NONTHABURI 11000 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 | 1989-07-14 |