FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇭 Thailand
Latex Examination Glove Powder Free (Ocean Blue and Natural White)
K Number: K240266
·
Decision Sep 9, 2024
Classifications
1
FEI Numbers
169
Registration Numbers
169
Same Product Code
1953
Applicant Total
7
Review Days
222
Basic Information
- Device Name
- Latex Examination Glove Powder Free (Ocean Blue and Natural White)
- K Number
- K240266
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sri Trang Gloves (Thailand) Public Company Limited
- Date Received
- January 31, 2024
- Decision Date
- September 9, 2024
- 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 Sri Trang Gloves (Thailand) Public Company Limited
| K Number | Device Name | ||
|---|---|---|---|
| K232614 | Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) | May 13, 2024 | Substantially Equivalent |
| K221165 | Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl | Nov 20, 2022 | Substantially Equivalent |
| K212482 | Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White | Aug 9, 2022 | Substantially Equivalent |
| K212309 | Non-sterile, Powder-Free Latex Examination Glove | Apr 8, 2022 | Substantially Equivalent |
| K200539 | Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl | Apr 9, 2020 | Substantially Equivalent |
| K193581 | Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster | Mar 20, 2020 | Substantially Equivalent |