FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇩 Indonesia
MAL LATEX EXAMINATION GLOVES
K Number: K896604
·
Decision Jan 2, 1990
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
11
Review Days
42
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Basic Information
- Device Name
- MAL LATEX EXAMINATION GLOVES
- K Number
- K896604
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Pt. Maja Agung Latexindo
- Date Received
- November 21, 1989
- Decision Date
- January 2, 1990
- 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
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Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
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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)
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Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
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Powder-Free Latex examination gloves
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Non Sterile Powder Free Latex Examination Glove
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Other Clearances by Pt. Maja Agung Latexindo
| K Number | Device Name | ||
|---|---|---|---|
| K212408 | Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) | May 18, 2022 | Substantially Equivalent |
| K161099 | Powder Free Nitrile Examination Gloves, Black | Feb 23, 2017 | Substantially Equivalent |
| K081488 | POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE | Aug 28, 2008 | Substantially Equivalent |
| K062709 | POWDER FREE LATEX EXAMINATION GLOVES, BLACK | Dec 6, 2006 | Substantially Equivalent |
| K020040 | LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM | Aug 1, 2002 | Substantially Equivalent |
| K013996 | LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE | Feb 26, 2002 | Substantially Equivalent |
| K001274 | LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Jun 23, 2000 | Substantially Equivalent |
| K994255 | LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE | Feb 7, 2000 | Substantially Equivalent |
| K992752 | SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5 | Nov 5, 1999 | Substantially Equivalent |
| K982897 | POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Dec 23, 1998 | Substantially Equivalent |