POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES

Polymer Patient Examination Glove

DEHAI (SHANDONG) MEDICAL GLOVES, CO., LTD

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.

Pre-market Notification Details

• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B845NGDM10483	K123869	000
D930253010490	K123869	000
D930253010480	K123869	000
D930253010470	K123869	000
D930253010460	K123869	000
D930253010450	K123869	000
00795847979298	K123869	000
00795847979281	K123869	000
00795847979274	K123869	000
03850004625733	K123869	000
03850004625757	K123869	000
B845NGDM10473	K123869	000
B845NGDM10463	K123869	000
B845NGDM10453	K123869	000
B845NGDM10443	K123869	000
B845NGDM10433	K123869	000
03850004625818	K123869	000
03850004625795	K123869	000
03850004625771	K123869	000
00795847979267	K123869	000
00795847979250	K123869	000
04897147760104	K123869	000
04897147760296	K123869	000
04897147760289	K123869	000
04897147760272	K123869	000
04897147760265	K123869	000
04897147760401	K123869	000
04897147760395	K123869	000
04897147760388	K123869	000
04897147760371	K123869	000
04897147760302	K123869	000
04897147760012	K123869	000
04897147760098	K123869	000
04897147760081	K123869	000
04897147760074	K123869	000
04897147760067	K123869	000
04897147760050	K123869	000
04897147760043	K123869	000
04897147760036	K123869	000
04897147760029	K123869	000
04897147760364	K123869	000
00810143550672	K123869	000
B845NGPF10473	K123869	000
B845NGPF10463	K123869	000
B845NGPF10453	K123869	000
B845NGPF10443	K123869	000
B845NGPF10433	K123869	000
B845NGHM10483	K123869	000
B845NGHM10473	K123869	000
B845NGHM10463	K123869	000
B845NGPF10483	K123869	000
B845NGXM10433	K123869	000
00810143550641	K123869	000
00810143550610	K123869	000
00810143550580	K123869	000
B845NGXM10483	K123869	000
B845NGXM10473	K123869	000
B845NGXM10463	K123869	000
B845NGXM10453	K123869	000
B845NGXM10443	K123869	000
B845NGHM10453	K123869	000
B845NGHM10443	K123869	000
B845NGHM10433	K123869	000
00850051992157	K123869	000
00850051992133	K123869	000
00850051992119	K123869	000
00850051992096	K123869	000
20860010351349	K123869	000
20860010351332	K123869	000
20860010351325	K123869	000
20860010351318	K123869	000
00850051992171	K123869	000
00850051992195	K123869	000
B845NGCM10483	K123869	000
B845NGCM10473	K123869	000
B845NGCM10463	K123869	000
B845NGCM10453	K123869	000
B845NGCM10443	K123869	000
B845NGCM10433	K123869	000
00850051992232	K123869	000
00850051992218	K123869	000
00860010351307	K123869	000