FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
K Number: K973059
·
Decision Nov 7, 1997
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
23
Review Days
81
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
- PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
- K Number
- K973059
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sri Johani Sdn. Bhd.
- Date Received
- August 18, 1997
- Decision Date
- November 7, 1997
- 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
Other 510(k) clearances with the same product code (LZA), ordered by most recent decision date.
Powder Free Nitrile Examination Gloves Non-Sterile Black
FDA 510(k)
FDA Class 1
·General Hospital
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)
FDA 510(k)
FDA Class 1
·General Hospital
Nitrile Disposable Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
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
FDA 510(k)
FDA Class 1
·General Hospital
Syntex Exam Gloves
FDA 510(k)
FDA Class 1
·General Hospital
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
Other Clearances by Sri Johani Sdn. Bhd.
| K Number | Device Name | ||
|---|---|---|---|
| K993454 | POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS) | Dec 3, 1999 | Substantially Equivalent |
| K993457 | POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS] | Dec 2, 1999 | Substantially Equivalent |
| K993458 | POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) | Nov 10, 1999 | Substantially Equivalent |
| K981039 | POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) | Apr 21, 1998 | Substantially Equivalent |
| K980037 | POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) | Feb 9, 1998 | Substantially Equivalent |
| K980038 | POWDERFREE GREEN LATEX EXAMINATION GLOVES | Feb 9, 1998 | Substantially Equivalent |
| K980039 | POWDERED GREEN LATEX EXAMINATION GLOVES | Feb 9, 1998 | Substantially Equivalent |
| K974886 | POWDERED GREEN NITRILE EXAMINATION GLOVES | Jan 30, 1998 | Substantially Equivalent |
| K974887 | POWDERFREE GREEN NITRILE EXAMINATION GLOVES | Jan 29, 1998 | Substantially Equivalent |
| K974183 | POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR) | Dec 18, 1997 | Substantially Equivalent |