POWER-FREE NITRILE PATIENT EXAMINATION GLOVES

Polymer Patient Examination Glove

SHANDONG JUNCHI MEDICAL PRODUCTS CO., LTD.

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

Pre-market Notification Details

• Device ID: K121526
• 510k Number: K121526
• Device Name: POWER-FREE NITRILE PATIENT EXAMINATION GLOVES
• Classification: Polymer Patient Examination Glove
• Applicant: SHANDONG JUNCHI MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE. Chino, CA 91710
• Contact: Cecily Sheng
• Correspondent: Cecily Sheng; SHANDONG JUNCHI 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: 2012-05-23
• Decision Date: 2012-08-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D1052116S100	K121526	000
26975878910462	K121526	000
26975878910455	K121526	000
26975878910448	K121526	000
26975878910431	K121526	000
26975878910424	K121526	000
26975878910417	K121526	000
16975878910403	K121526	000
26975878910394	K121526	000
26975878910387	K121526	000
26975878910370	K121526	000
26975878910363	K121526	000
06975878910352	K121526	000
26975878910349	K121526	000
D105211520L2000	K121526	000
D105211520M2000	K121526	000
D105211520S2000	K121526	000
D1052317M3000	K121526	000
D1052317M3	K121526	000
D1052217M2000	K121526	000
D1052217M200	K121526	000
D1052117M1000	K121526	000
D1052318L3000	K121526	000
D1052318L3	K121526	000
D1052218L2000	K121526	000
D1052218L200	K121526	000
D1052118L1000	K121526	000
D1052118L100	K121526	000
D105211520XS2000	K121526	000
D105211520XL2000	K121526	000
26975878910332	K121526	000
26975878910325	K121526	000
B845NGHM10183	K121526	000
B845NGHM10173	K121526	000
B845NGHM10163	K121526	000
B845NGHM10153	K121526	000
B845NGHM10143	K121526	000
B845NGHM1013	K121526	000
B845NGDM10183	K121526	000
B845NGDM10173	K121526	000
B845NGDM10163	K121526	000
B845NGDM10153	K121526	000
B845NGDM10143	K121526	000
B845NGDM10133	K121526	000
08401173341686	K121526	000
03850004625733	K121526	000
03850004625757	K121526	000
03850004625771	K121526	000
06975878910314	K121526	000
06975878910307	K121526	000
26975878910530	K121526	000
26975878910523	K121526	000
26975878910516	K121526	000
26975878910509	K121526	000
26975878910493	K121526	000
26975878910486	K121526	000
26975878910479	K121526	000
10342509000103	K121526	000
06970245755277	K121526	000
03850004625818	K121526	000
03850004625795	K121526	000
00840117334151	K121526	000
D1052116S1000	K121526	000
00196852952410	K121526	000
B845NGPF10333	K121526	000
B845NGBM10283	K121526	000
B845NGBM10273	K121526	000
B845NGBM10263	K121526	000
B845NGBM10253	K121526	000
B845NGBM10243	K121526	000
B845NGBM10233	K121526	000
10850047958997	K121526	000
B845NGXM10183	K121526	000
B845NGXM10173	K121526	000
B845NGXM10163	K121526	000
B845NGXM10153	K121526	000
B845NGXM10143	K121526	000
B845NGPF10343	K121526	000
B845NGPF10353	K121526	000
B845NGPF10363	K121526	000
00196852902323	K121526	000
00196852445684	K121526	000
00196852240364	K121526	000
18960085001059	K121526	000
B845NGPF70053	K121526	000
B845NGPF70043	K121526	000
B845NGPF70033	K121526	000
B845NGPF70023	K121526	000
B845NGPF70013	K121526	000
B845NGPF70003	K121526	000
00840369314192	K121526	000
B845NGPF10383	K121526	000
B845NGPF10373	K121526	000
B845NGXM10133	K121526	000
B845NGVM10173	K121526	000
D1052215XS2000	K121526	000
D1052215XS200	K121526	000
D1052115XS1000	K121526	000
D1052115XS100	K121526	000
D1052319XL3000	K121526	000
D1052319XL3	K121526	000
D1052219XL2000	K121526	000
D1052219XL200	K121526	000
D1052119XL1000	K121526	000
D1052119XL100	K121526	000
D1052316S3000	K121526	000
D1052316S3	K121526	000
D1052216S2000	K121526	000
D1052315XS3	K121526	000
D1052315XS3000	K121526	000
00850051992010	K121526	000
B845NGVM10163	K121526	000
B845NGVM10153	K121526	000
B845NGVM10143	K121526	000
B845NGVM10133	K121526	000
B845NGPM10183	K121526	000
B845NGPM10173	K121526	000
B845NGPM10163	K121526	000
B845NGPM10153	K121526	000
B845NGPM10143	K121526	000
B845NGPM10133	K121526	000
00850051992072	K121526	000
00850051992058	K121526	000
00850051992034	K121526	000
D1052216S200	K121526	000