The following data is part of a premarket notification filed by B-care Industries Co., Ltd. with the FDA for B-care Powder Free Latex Examination Gloves.
| Device ID | K051404 |
| 510k Number | K051404 |
| Device Name: | B-CARE POWDER FREE LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | B-CARE INDUSTRIES CO., LTD. 11 CHOTIVITHAYAKUL 3 ROAD T. HATYAI Hatyai, Songkhla, TH 90110 |
| Contact | Rujira Phanphiphat |
| Correspondent | Rujira Phanphiphat B-CARE INDUSTRIES CO., LTD. 11 CHOTIVITHAYAKUL 3 ROAD T. HATYAI 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 | 2005-05-31 |
| Decision Date | 2005-09-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10699320107956 | K051404 | 000 |
| 10818566010633 | K051404 | 000 |
| 10818566010640 | K051404 | 000 |
| 10818566010657 | K051404 | 000 |
| 10818566010664 | K051404 | 000 |
| 10699320102012 | K051404 | 000 |
| 10699320102029 | K051404 | 000 |
| 10699320102036 | K051404 | 000 |
| 10699320102043 | K051404 | 000 |
| 10699320102050 | K051404 | 000 |
| 00041415028746 | K051404 | 000 |
| 10699320107918 | K051404 | 000 |
| 10699320107925 | K051404 | 000 |
| 10699320107932 | K051404 | 000 |
| 10699320107949 | K051404 | 000 |
| 10818566010626 | K051404 | 000 |