FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Non-spermicidal Lubricated Male Latex Condom
K Number: K193578
·
Decision Aug 20, 2020
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
400
Applicant Total
11
Review Days
241
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Basic Information
- Device Name
- Non-spermicidal Lubricated Male Latex Condom
- K Number
- K193578
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Global Protection Corp.
- Date Received
- December 23, 2019
- Decision Date
- August 20, 2020
- Product Code
- HIS
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HIS | Condom | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIS), ordered by most recent decision date.
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Other Clearances by Global Protection Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K250142 | Water-based Lubricant | Aug 8, 2025 | Substantially Equivalent |
| K243972 | Plain Water-based Lubricant | Aug 8, 2025 | Substantially Equivalent |
| K243967 | ONE Nitrile Condom | Apr 8, 2025 | Substantially Equivalent |
| K240896 | ONE Nitrile Condom | Aug 23, 2024 | Substantially Equivalent |
| K223214 | Powder-Free Nitrile Examination Gloves | Sep 21, 2023 | Substantially Equivalent |
| K213087 | Natural Rubber Latex Ultrasound Transducer Probe Covers | Jun 7, 2022 | Substantially Equivalent |
| DEN210034 | ONE Male Condom | Feb 23, 2022 | Unknown |
| K203536 | Male Latex Condom | Sep 3, 2021 | Substantially Equivalent |
| K024324 | LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 | Mar 25, 2003 | Substantially Equivalent |
| K960552 | KNIGHT LIGHT NONLUBRICATED CONDOM | Nov 20, 1997 | Substantially Equivalent |