The following data is part of a premarket notification filed by Thai Chong Chemical Industrial Co., Ltd. with the FDA for Patient Examination Gloves (latex).
| Device ID | K893090 |
| 510k Number | K893090 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | THAI CHONG CHEMICAL INDUSTRIAL CO., LTD. NANTHAPOL BLDG., 469/18-20 LEABRIMMAENUM RD. Bangkok, Thailand, TH |
| Contact | Tom Dao |
| Correspondent | Tom Dao THAI CHONG CHEMICAL INDUSTRIAL CO., LTD. NANTHAPOL BLDG., 469/18-20 LEABRIMMAENUM RD. Bangkok, 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 | 1989-04-13 |
| Decision Date | 1989-07-14 |