FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
K Number: K223298
·
Decision Feb 22, 2023
Classifications
1
FEI Numbers
169
Registration Numbers
169
Same Product Code
1953
Applicant Total
4
Review Days
118
Basic Information
- Device Name
- Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
- K Number
- K223298
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shandong Intco Medical Products Co, Ltd.
- Date Received
- October 27, 2022
- Decision Date
- February 22, 2023
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYY), ordered by most recent decision date.
Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
FDA 510(k)
FDA Class 1
·General Hospital
Latex Examination Glove Powder Free (Ocean Blue and Natural White)
FDA 510(k)
FDA Class 1
·General Hospital
Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
FDA 510(k)
FDA Class 1
·General Hospital
Powder-Free Latex examination gloves
FDA 510(k)
FDA Class 1
·General Hospital
Non Sterile Powder Free Latex Examination Glove
FDA 510(k)
FDA Class 1
·General Hospital
JR MEDIC
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Shandong Intco Medical Products Co, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K233042 | Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Dec 6, 2023 | Substantially Equivalent |
| K231408 | Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile | Aug 11, 2023 | Substantially Equivalent |
| K213509 | Latex Examination Gloves, Powder Free | Apr 8, 2022 | Substantially Equivalent |