GLOBAL PROTECTION CORP.

FDA Device Registration & Listing · Lynn, MA, US · Registration 1222115

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1222115
FEI Number
1222115
Entity Name
GLOBAL PROTECTION CORP.
City/State/Country
Lynn, MA, US
Establishment Address
630 Lynnway, Lynn, MA 01905, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Global Protection Corp. (Owner Number: 9008037)
Owner / Operator Contact Address
630 Lynnway, Lynn, MA 01905, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K081886
PMA Number
N/A

All Registered Proprietary Names

Pasante Glowing FC2 Female Condom Custom Condom Extra Large Powder Free Nitrile Examination Gloves ONE FLEX Satin Dams

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QRZ External Condom For Anal Intercourse Or Vaginal Intercourse Obstetrics/Gynecology Class 2 884.5305 2023-03-30
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2007-12-21
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2007-12-13
MBU Single-Use Internal Condom Obstetrics/Gynecology Class 2 884.5340 2022-05-11
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2017-05-01
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2026-03-27
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2017-04-19
MOL Condom, Synthetic Obstetrics/Gynecology Class 2 884.5300 2025-05-06
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2017-06-12
MSC Barrier, Std, Oral Sex Obstetrics/Gynecology Class 2 884.5300 2026-02-13
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2012-10-09
MOL Condom, Synthetic Obstetrics/Gynecology Class 2 884.5300 2024-09-16
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-09-25
MOL Condom, Synthetic Obstetrics/Gynecology Class 2 884.5300 2026-02-09
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2017-04-19
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2017-06-12
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2017-04-19
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2022-05-23
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2007-12-21
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2017-04-19
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2017-04-19
MSC Barrier, Std, Oral Sex Obstetrics/Gynecology Class 2 884.5300 2015-12-09
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2012-06-27
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2019-05-01
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2017-11-22
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2025-09-23
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2017-04-19

Official Correspondent

Davin Wedel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Global Protection Corp.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K050212 Qualis, Inc. PERSONAL WARMING JELLY 2005-03-17
K212801 Hong Seng Gloves Sdn Bhd Powder free nitrile examination glove- black, non sterile 2022-01-09
K260806 Vista Industries,, LLC Nitrile Disposable Examination Gloves 2026-06-03
K011593 Ansell Healthcare Products, Inc. MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE 2001-06-21
K981039 Sri Johani Sdn. Bhd. POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) 1998-04-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222115. Last updated year: 2026. Please use registration number 1222115 when referencing this establishment in official correspondence.
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