Device Classification Name |
latex patient examination glove |
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---|---|---|---|---|
510(k) Number | K960225 | |||
Device Name | POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) PATIENT EXAMINATION GLOVES | |||
Applicant |
|
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Applicant Contact | imogene tibbetts | |||
Correspondent |
|
|||
Correspodent Contact | imogene tibbetts | |||
Regulation Number | 880.6250 | |||
Classification Product Code |
|
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Date Received | 01/17/1996 | |||
Decision Date | 07/29/1996 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
General Hospital |
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510k Review Panel |
General Hospital |
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summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |