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535
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521
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517
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Polymer Patient Examination Glove
489
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431
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406
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401
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Manufacturers
US
Biopro, Inc.
Medical Device Manufacturer
·
US , Port Huron , MI
Biopro, Inc. - FDA 510(k) Cleared Devices
41 submissions
·
35 cleared
·
Since 1987
41
Total
35
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biopro, Inc.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
May 24, 1996
POWDER FREE LATEX EXAMINATION GLOVE
K960467
·
LYY
General Hospital
·
115d
Cleared
Dec 14, 1987
REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE
K874099
·
KGO
General Hospital
·
67d
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41
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39
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2