The following data is part of a premarket notification filed by Siamount Plastic Corporation Ltd. with the FDA for Plastic (vinyl) Examination Gloves.
| Device ID | K910879 |
| 510k Number | K910879 |
| Device Name: | PLASTIC (VINYL) EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SIAMOUNT PLASTIC CORPORATION LTD. 1016 CATHAY TRUST BLDG. 2ND FL.RAMA 4 RD Bangkok, TH 10500 |
| Contact | Srifuengfung |
| Correspondent | Srifuengfung SIAMOUNT PLASTIC CORPORATION LTD. 1016 CATHAY TRUST BLDG. 2ND FL.RAMA 4 RD Bangkok, TH 10500 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-01 |
| Decision Date | 1991-04-25 |