The following data is part of a premarket notification filed by Dehai (shandong) Medical Gloves, Co., Ltd with the FDA for Powder-free Nitrile Patient Examination Gloves.
| Device ID | K123869 |
| 510k Number | K123869 |
| Device Name: | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | DEHAI (SHANDONG) MEDICAL GLOVES, CO., LTD 12390 EAST END AVE. Chino, CA 91710 |
| Contact | Ray Zhou |
| Correspondent | Ray Zhou DEHAI (SHANDONG) MEDICAL GLOVES, CO., LTD 12390 EAST END AVE. Chino, CA 91710 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-17 |
| Decision Date | 2013-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00795847979250 | K123869 | 000 |
| B845NGDM10453 | K123869 | 000 |
| B845NGDM10463 | K123869 | 000 |
| B845NGDM10473 | K123869 | 000 |
| B845NGDM10483 | K123869 | 000 |
| 00860010351307 | K123869 | 000 |
| 20860010351318 | K123869 | 000 |
| 20860010351325 | K123869 | 000 |
| 20860010351332 | K123869 | 000 |
| 20860010351349 | K123869 | 000 |
| 00850051992096 | K123869 | 000 |
| 00850051992119 | K123869 | 000 |
| 00850051992133 | K123869 | 000 |
| 00850051992157 | K123869 | 000 |
| B845NGDM10443 | K123869 | 000 |
| B845NGDM10433 | K123869 | 000 |
| 03850004625818 | K123869 | 000 |
| 00795847979267 | K123869 | 000 |
| 00795847979274 | K123869 | 000 |
| 00795847979281 | K123869 | 000 |
| 00795847979298 | K123869 | 000 |
| D930253010450 | K123869 | 000 |
| D930253010460 | K123869 | 000 |
| D930253010470 | K123869 | 000 |
| D930253010480 | K123869 | 000 |
| D930253010490 | K123869 | 000 |
| 03850004625733 | K123869 | 000 |
| 03850004625757 | K123869 | 000 |
| 03850004625771 | K123869 | 000 |
| 03850004625795 | K123869 | 000 |
| 00850051992171 | K123869 | 000 |
| 00850051992195 | K123869 | 000 |
| B845NGPF10453 | K123869 | 000 |
| B845NGPF10463 | K123869 | 000 |
| B845NGPF10473 | K123869 | 000 |
| B845NGPF10483 | K123869 | 000 |
| B845NGXM10433 | K123869 | 000 |
| B845NGXM10443 | K123869 | 000 |
| B845NGXM10453 | K123869 | 000 |
| B845NGXM10463 | K123869 | 000 |
| B845NGXM10473 | K123869 | 000 |
| B845NGXM10483 | K123869 | 000 |
| 00810143550580 | K123869 | 000 |
| 00810143550610 | K123869 | 000 |
| 00810143550641 | K123869 | 000 |
| B845NGPF10443 | K123869 | 000 |
| B845NGPF10433 | K123869 | 000 |
| B845NGHM10483 | K123869 | 000 |
| 00850051992218 | K123869 | 000 |
| 00850051992232 | K123869 | 000 |
| B845NGCM10433 | K123869 | 000 |
| B845NGCM10443 | K123869 | 000 |
| B845NGCM10453 | K123869 | 000 |
| B845NGCM10463 | K123869 | 000 |
| B845NGCM10473 | K123869 | 000 |
| B845NGCM10483 | K123869 | 000 |
| B845NGHM10433 | K123869 | 000 |
| B845NGHM10443 | K123869 | 000 |
| B845NGHM10453 | K123869 | 000 |
| B845NGHM10463 | K123869 | 000 |
| B845NGHM10473 | K123869 | 000 |
| 00810143550672 | K123869 | 000 |