| Device Classification Name |
polymer patient examination glove |
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|---|---|---|---|---|
| 510(k) Number | K992210 | |||
| Device Name | SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES | |||
| Applicant |
|
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| Applicant Contact | eugene v goorchenko | |||
| Correspondent |
|
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| Correspodent Contact | eugene v goorchenko | |||
| Regulation Number | 880.6250 | |||
| Classification Product Code |
|
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| Date Received | 07/01/1999 | |||
| Decision Date | 09/10/1999 | |||
| 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 |