POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR

Polymer Patient Examination Glove

SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD.

The following data is part of a premarket notification filed by Shandong Baisheng Medical Products Co., Ltd. with the FDA for Powder-free Nitrile Patient Examination Gloves, Blue Color.

Pre-market Notification Details

• Device ID: K112294
• 510k Number: K112294
• Device Name: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
• Classification: Polymer Patient Examination Glove
• Applicant: SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE. Chino, CA 91710
• Contact: Frank Liu
• Correspondent: Frank Liu; SHANDONG BAISHENG MEDICAL PRODUCTS 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: 2011-08-10
• Decision Date: 2012-04-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850052602208	K112294	000
D1052115XS1000	K112294	000
D1052215XS1	K112294	000
D1052115XS1	K112294	000
D1052219XL1000	K112294	000
D1052119XL1000	K112294	000
D1052219XL1	K112294	000
D1052119XL1	K112294	000
D1052216S1000	K112294	000
D1052116S1000	K112294	000
D1052216S1	K112294	000
D1052116S1	K112294	000
D1052217M1000	K112294	000
D1052117M1000	K112294	000
D1052215XS1000	K112294	000
00810115891246	K112294	000
00850052602215	K112294	000
00850052602079	K112294	000
00850052602062	K112294	000
00850052602055	K112294	000
00850052602048	K112294	000
00850052602031	K112294	000
00850052602024	K112294	000
00850052602017	K112294	000
B845NGXM10183	K112294	000
B845NGXM10173	K112294	000
B845NGXM10163	K112294	000
B845NGXM10153	K112294	000
B845NGXM10143	K112294	000
B845NGXM10133	K112294	000
D1052217M1	K112294	000
D1052117M1	K112294	000
00810132800016	K112294	000
10810132800150	K112294	000
10810132800143	K112294	000
10810132800136	K112294	000
10810132800129	K112294	000
10810132800112	K112294	000
10810132800105	K112294	000
10810132800099	K112294	000
10810132800082	K112294	000
10810132800068	K112294	000
10810132800051	K112294	000
10810132800044	K112294	000
10810132800037	K112294	000
10810132800075	K112294	000
00850030415479	K112294	000
00850030415486	K112294	000
D1052218L1000	K112294	000
D1052118L1000	K112294	000
D1052218L1	K112294	000
D1052118L1	K112294	000
00810115891277	K112294	000
00810115891215	K112294	000
00810115891185	K112294	000
20850052497037	K112294	000
10850052497023	K112294	000
10850052497016	K112294	000
10850052497009	K112294	000
00850030415547	K112294	000
00850030415530	K112294	000
10810132800020	K112294	000
00860009119833	K112294	000
B845NGVM10153	K112294	000
B845NGVM10143	K112294	000
B845NGVM10133	K112294	000
B845NGPM10183	K112294	000
B845NGPM10173	K112294	000
B845NGPM10163	K112294	000
B845NGPM10153	K112294	000
B845NGPM10143	K112294	000
B845NGPM10133	K112294	000
00850050419037	K112294	000
00850050419020	K112294	000
00850050419013	K112294	000
00850050419006	K112294	000
B845NGVM10163	K112294	000
B845NGVM10173	K112294	000
08106760337720	K112294	000
00860009119826	K112294	000
00860009119819	K112294	000
00860009119888	K112294	000
09557621701683	K112294	000
09557621701584	K112294	000
09557621701577	K112294	000
08106760343806	K112294	000
08106760343738	K112294	000
08106760343660	K112294	000
08106760343424	K112294	000
08106760338024	K112294	000
08106760337966	K112294	000
08106760337898	K112294	000
30810054144916	K112294	000
30810054144909	K112294	000
00850046814860	K112294	000
00850046814853	K112294	000
00850046814815	K112294	000
00850046814808	K112294	000
00850046814792	K112294	000
00850051992072	K112294	000
00850051992058	K112294	000
00850051992034	K112294	000
00850051992010	K112294	000
00850046814846	K112294	000
00850046814839	K112294	000
00850046814822	K112294	000
10850052602007	K112294	000
00860010386477	K112294	000
00860010386460	K112294	000
00860010386453	K112294	000
30810054144893	K112294	000
30810054144886	K112294	000
30810054144831	K112294	000
30810054144824	K112294	000
30810054144817	K112294	000
30810054144800	K112294	000
06973658651532	K112294	000
06973658651389	K112294	000
06973658651396	K112294	000
06973658651402	K112294	000
06973658651419	K112294	000
18960085001059	K112294	000
00860010386446	K112294	000
00850052602239	K112294	000