FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
K Number: K161473
·
Decision Oct 19, 2016
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
238
Review Days
145
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Basic Information
- Device Name
- Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
- K Number
- K161473
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medline Industries, Inc.
- Date Received
- May 27, 2016
- Decision Date
- October 19, 2016
- Product Code
- LZA
- 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 |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl
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FDA 510(k)
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Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
FDA 510(k)
FDA Class 1
·General Hospital
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