FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)
K Number: K071910
·
Decision Sep 6, 2007
Classifications
1
FEI Numbers
444
Registration Numbers
445
Same Product Code
1158
Applicant Total
46
Review Days
57
Basic Information
- Device Name
- NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)
- K Number
- K071910
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- HARTALEGA SDN BHD
- Date Received
- July 11, 2007
- Decision Date
- September 6, 2007
- 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 |
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Other Clearances by HARTALEGA SDN BHD
| K Number | Device Name | ||
|---|---|---|---|
| K170152 | POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) | May 5, 2017 | Substantially Equivalent |
| K160560 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) | Aug 4, 2016 | Substantially Equivalent |
| K150593 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) | Jun 9, 2015 | Substantially Equivalent |
| K150103 | Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs | Apr 23, 2015 | Substantially Equivalent |
| K142588 | Nitrile Powder Free Examination Glove (Blue) | Dec 18, 2014 | Substantially Equivalent |
| K140050 | NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE | Sep 12, 2014 | Substantially Equivalent |
| K133956 | NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN | May 28, 2014 | Substantially Equivalent |
| K133953 | LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M | May 28, 2014 | Substantially Equivalent |
| K132006 | STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU) | Nov 7, 2013 | Substantially Equivalent |
| K130473 | NITRILE POWDER FREE EXAMINATION GLOVE (ABLU) | Jul 5, 2013 | Substantially Equivalent |