FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇭 Thailand
OMNI PRO LATEX SURGICAL GLOVE, POWDERED
K Number: K982613
·
Decision Sep 2, 1998
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
558
Applicant Total
12
Review Days
37
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OMNI PRO LATEX SURGICAL GLOVE, POWDERED
- K Number
- K982613
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4460
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Omnigrace (Thailand) , Ltd.
- Date Received
- July 27, 1998
- Decision Date
- September 2, 1998
- Product Code
- KGO
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KGO | Surgeon'S Gloves | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGO), ordered by most recent decision date.
Sterile Latex Powder Free Surgical Gloves
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Polyisoprene Surgical gloves
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| K993479 | OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS) | Nov 19, 1999 | 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 |
| K980419 | OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE | Mar 13, 1998 | Substantially Equivalent |