| Device Classification Name |
polymer patient examination glove |
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|---|---|---|---|---|---|
| 510(k) Number | K992360 | ||||
| Device Name | TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES | ||||
| Applicant |
|
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| Applicant Contact | wee-chai lim | ||||
| Correspondent |
|
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| Correspodent Contact | wee-chai lim | ||||
| Regulation Number | 880.6250 | ||||
| Classification Product Code |
|
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| Date Received | 07/15/1999 | ||||
| Decision Date | 10/12/1999 | ||||
| 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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| statement |
statement |
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| Type | Traditional | ||||
| Reviewed by Third Party | No | ||||
| Combination Product |
No |