Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, And Tested For Use With Chemotherapy Drugs

Polymer Patient Examination Glove

SHANDONG FEIYANG PROFESSIONAL GLOVES CO., LTD

The following data is part of a premarket notification filed by Shandong Feiyang Professional Gloves Co., Ltd with the FDA for Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, And Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

• Device ID: K170136
• 510k Number: K170136
• Device Name: Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, And Tested For Use With Chemotherapy Drugs
• Classification: Polymer Patient Examination Glove
• Applicant: SHANDONG FEIYANG PROFESSIONAL GLOVES CO., LTD 338 HUAQING DRIVE QIXIN CHEMICAL INDUSTRY ZONE Qingzhou, CN 255000
• Contact: Ken Lu
• Correspondent: Xiaofei Hao; BASIC MEDICAL INDUSTRIES. INC. 805 BARRINGTON AVE Ontario, CA 91764
• Product Code: LZA
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-01-17
• Decision Date: 2017-08-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850053354427	K170136	000
B845ANBM100333	K170136	000
D1054119XL100	K170136	000
D1054118L100	K170136	000
D1056116XS3000	K170136	000
D1056116XS3	K170136	000
D1056116XL3000	K170136	000
D1056116XL3	K170136	000
D1056116S3000	K170136	000
D1056116S3	K170136	000
D1056116M3000	K170136	000
B845ANBM100343	K170136	000
B845ANBM100353	K170136	000
00850053354397	K170136	000
00850053354366	K170136	000
00850053354335	K170136	000
00850053354304	K170136	000
00850053354274	K170136	000
D1054119L1000	K170136	000
D1054118L1000	K170136	000
D1054118L1	K170136	000
B845ANBM100373	K170136	000
B845ANBM100363	K170136	000
D1056116M3	K170136	000
D1056116L3000	K170136	000
00850014448264	K170136	000
00850014448240	K170136	000
00850014448226	K170136	000
00850014448202	K170136	000
00850014448189	K170136	000
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00810073734784	K170136	000
20708820383726	K170136	000
00612479268982	K170136	000
00810054145738	K170136	000
D1056116L3	K170136	000
15060887690611	K170136	000
00850052096663	K170136	000
00850052096656	K170136	000
00850052096649	K170136	000
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00810054145769	K170136	000
00810054145752	K170136	000
00810054145745	K170136	000
80080196028916	K170136	000
00850053354458	K170136	000
30680651473777	K170136	000
B845ANBM100141	K170136	000
00850020592920	K170136	000
00850020592913	K170136	000
00850020592906	K170136	000
00850020592890	K170136	000
D1055116XL200	K170136	000
D1055116S200	K170136	000
D1055116M200	K170136	000
D1055116L200	K170136	000
D1054116XL100	K170136	000
00850020592432	K170136	000
00850020592449	K170136	000
30680651473760	K170136	000
30680651473753	K170136	000
30680651473746	K170136	000
30680651473739	K170136	000
20885632295321	K170136	000
20885632295314	K170136	000
20885632295307	K170136	000
20885632295291	K170136	000
00850020592463	K170136	000
00850020592456	K170136	000
D1054116S100	K170136	000
D1054116S1001	K170136	000
15060887690574	K170136	000
15060887690567	K170136	000
35060887690554	K170136	000
15060887690543	K170136	000
15060887690536	K170136	000
15060887690529	K170136	000
M2089004051C2	K170136	000
M2089004050C2	K170136	000
M2089004049C2	K170136	000
M2089004048C2	K170136	000
15060887690581	K170136	000
D056116MBLK100	K170136	000
D1054116M100	K170136	000
D1054116L100	K170136	000
D79010685053	K170136	000
D79010685043	K170136	000
D79010685033	K170136	000
D79010685023	K170136	000
D79010685013	K170136	000
D056116SBLKCASE100	K170136	000
D056116SBLK100	K170136	000
D056116MBLKCASE100	K170136	000
00850053354489	K170136	000