FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE
K Number: K982416
·
Decision Nov 24, 1998
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
6
Review Days
134
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Basic Information
- Device Name
- SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE
- K Number
- K982416
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shun Thai Rubber Gloves Industry Co., Ltd.
- Date Received
- July 13, 1998
- Decision Date
- November 24, 1998
- 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 |
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Other Clearances by Shun Thai Rubber Gloves Industry Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K051333 | NITRILE EXAMINATION GLOVES, POWDER FREE | Jul 22, 2005 | Substantially Equivalent |
| K952695 | BOSTON MEDICAL LATEX EXAM GLOVES | Aug 11, 1995 | Substantially Equivalent |
| K930139 | HYPO-ALLERGENIC PATIENT EXAMINATION GLOVES | Aug 24, 1993 | Substantially Equivalent |
| K892554 | STERILE PATIENT EXAMINATION GLOVE | May 25, 1989 | Substantially Equivalent |
| K891300 | NON-STERILE PATIENT EXAMINATION GLOVE | Apr 5, 1989 | Substantially Equivalent |