The following data is part of a premarket notification filed by Southland Products Co., Ltd. with the FDA for Southland Powderfree Latex Examination Gloves With Protein Label Claim.
| Device ID | K990746 |
| 510k Number | K990746 |
| Device Name: | SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM |
| Classification | Latex Patient Examination Glove |
| Applicant | SOUTHLAND PRODUCTS CO., LTD. 55 RAJYINDEE RD. Hatyai, Songkhla, TH 90110 |
| Contact | Ng Peng Leong |
| Correspondent | Ng Peng Leong SOUTHLAND PRODUCTS CO., LTD. 55 RAJYINDEE RD. Hatyai, Songkhla, TH 90110 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-08 |
| Decision Date | 1999-03-23 |