FDA Registration
Active
🇺🇸 United States
GLOBAL PROTECTION CORP.
Reg #: 1222115
·
FEI: 1222115
·
Expires 2026
Products
7
Proprietary Names
15
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- GLOBAL PROTECTION CORP.
- Registration Number
- 1222115
- FEI Number
- 1222115
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 630 Lynnway
- City
- Lynn
- State
- MA
- ZIP
- 01905
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN210034
- PMA Number
- P080002
Owner / Operator
- Firm Name
- Global Protection Corp.
- Operator Number
- 9008037
- Address
- 630 Lynnway
- City
- Lynn
- State
- MA
- Postal Code
- 01905
- Country
- US
- Correspondent
- Davin Wedel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| External Condom For Anal Intercourse Or Vaginal Intercourse | QRZ | Class 2 | Obstetrics/Gynecology | No | 2023-03-30 |
| Condom | HIS | Class 2 | Obstetrics/Gynecology | No | 2007-12-21 |
| Single-Use Internal Condom | MBU | Class 2 | Obstetrics/Gynecology | No | 2022-05-11 |
| Condom, Synthetic | MOL | Class 2 | Obstetrics/Gynecology | No | 2025-05-06 |
| Barrier, Std, Oral Sex | MSC | Class 2 | Obstetrics/Gynecology | No | 2026-02-13 |
| Lubricant, Personal | NUC | Class 2 | Obstetrics/Gynecology | No | 2012-10-09 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-09-25 |
Proprietary Names
Pasante Glowing
FC2 Female Condom
Custom Condom Extra Large
Powder Free Nitrile Examination Gloves
ONE FLEX
Satin Dams
MyONE O31
MyONE U31
MyONE N31
MyONE Z31
MyONE D31
Adam & Eve Hard Rider Studded Condom
NuVo Ultra Sensitive
Dame Ultra Thin Condoms
Swoon Ultra Thin
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility