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.
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 |
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 |