FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇭 Thailand
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS)
K Number: K993479
·
Decision Nov 19, 1999
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
12
Review Days
36
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Basic Information
- Device Name
- OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS)
- K Number
- K993479
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Omnigrace (Thailand) , Ltd.
- Date Received
- October 14, 1999
- Decision Date
- November 19, 1999
- Product Code
- LYY
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | FDA class 1 | General Hospital |
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Other Clearances by Omnigrace (Thailand) , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K012402 | OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM | Oct 12, 2001 | Substantially Equivalent |
| K002922 | OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS) | Oct 16, 2000 | Substantially Equivalent |
| K990698 | OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE | May 13, 1999 | Substantially Equivalent |
| K990696 | OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE | May 13, 1999 | Substantially Equivalent |
| K990701 | OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE | May 5, 1999 | Substantially Equivalent |
| K990695 | OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE | May 4, 1999 | Substantially Equivalent |
| K990702 | OMNI GRACE LATEX EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED WITH PROTEIN CLAIM | May 4, 1999 | Substantially Equivalent |
| K982716 | OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE, WITH PROTEIN CLAIM | Nov 30, 1998 | Substantially Equivalent |
| K982613 | OMNI PRO LATEX SURGICAL GLOVE, POWDERED | Sep 2, 1998 | Substantially Equivalent |
| K980419 | OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE | Mar 13, 1998 | Substantially Equivalent |