WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR

Polymer Patient Examination Glove

WANGHUI GLOVE CO., LTD.

The following data is part of a premarket notification filed by Wanghui Glove Co., Ltd. with the FDA for Wanghui Nitrile Powder Free Patient Examination Gloves, Blue Color.

Pre-market Notification Details

• Device ID: K141279
• 510k Number: K141279
• Device Name: WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
• Classification: Polymer Patient Examination Glove
• Applicant: WANGHUI GLOVE CO., LTD. ROOM 1606 BLDG 1, JIANXIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD, HAIDIAN DIS Beijing, CN 100083
• Contact: Chu Xiaoan
• Correspondent: Chu Xiaoan; WANGHUI GLOVE CO., LTD. ROOM 1606 BLDG 1, JIANXIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD, HAIDIAN DIS Beijing, CN 100083
• Product Code: LZA
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-05-16
• Decision Date: 2014-12-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10699320497255	K141279	000
10699320402617	K141279	000
10699320402624	K141279	000
10699320402631	K141279	000
10699320402648	K141279	000
10699320402655	K141279	000
10699320497224	K141279	000
10699320497231	K141279	000
10699320497248	K141279	000
00699320000670	K141279	000