The following data is part of a premarket notification filed by B-care Industries Co., Ltd. with the FDA for B-care Powdered Latex Examination Gloves.
| Device ID | K052845 |
| 510k Number | K052845 |
| Device Name: | B-CARE POWDERED LATEX EXAMINATION GLOVES |
| Classification | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
| Applicant | B-CARE INDUSTRIES CO., LTD. 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls B-CARE INDUSTRIES CO., LTD. 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | OPE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-07 |
| Decision Date | 2005-12-16 |