Data / Medical devices / United States / Global Protection Corp.
Global Protection Corp.: FDA-registered device maker in Lynn, MA, United States, 31 510(k) clearances and 1 PMA approval
Global Protection Corp. is registered with the FDA (registration 1222115) in Lynn, MA, United States. It lists 7 device types. The FDA files 31 510(k) clearances and 1 PMA approval under its listings, the newest dated August 8, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1222115
- Address
- 630 Lynnway, Lynn, MA, United States, 01905
- Owner or operator
- Global Protection Corp. (9008037)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- December 13, 2007
- Registered through
- 2026
- Brand names listed
- Adam & Eve Hard Rider Studded Condom, Custom Condom Extra Large, Dame Ultra Thin Condoms, FC2 Female Condom, MyONE D31, MyONE N31, MyONE O31, MyONE U31 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Std, Oral Sex | MSC | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Condom | HIS | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Condom, Synthetic | MOL | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| External Condom For Anal Intercourse Or Vaginal Intercourse | QRZ | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Single-Use Internal Condom | MBU | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 8, 2025 | K250142 | Water-based Lubricant | NUC | Substantially Equivalent | Global Protection Corp. | accessdata.fda.gov |
| August 8, 2025 | K243972 | Plain Water-based Lubricant | NUC | Substantially Equivalent | Global Protection Corp. | accessdata.fda.gov |
| April 8, 2025 | K243967 | ONE Nitrile Condom | MOL | Substantially Equivalent | Global Protection Corp. | accessdata.fda.gov |
| February 21, 2025 | K243640 | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy) | HIS | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| October 8, 2024 | K240379 | TROJAN SIS Synthetic Latex Condom with Silicone Lubricant | MOL | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| August 23, 2024 | K240896 | ONE Nitrile Condom | MOL | Substantially Equivalent | Global Protection Corp. | accessdata.fda.gov |
| September 21, 2023 | K223214 | Powder-Free Nitrile Examination Gloves | LZA | Substantially Equivalent | Global Protection Corp. | accessdata.fda.gov |
| August 11, 2023 | K223519 | Carex Hybrid Personal Lubricant | NUC | Substantially Equivalent | Karex Industries Sdn. Bhd. | accessdata.fda.gov |
| February 23, 2022 | DEN210034 | ONE Male Condom | QRZ | Unknown | Global Protection Corp. | accessdata.fda.gov |
| September 3, 2021 | K203536 | Male Latex Condom | HIS | Substantially Equivalent | Global Protection Corp. | accessdata.fda.gov |
| August 5, 2021 | K203727 | Harmony Latex Dam, Harmony Non-Latex Dam | MSC | Substantially Equivalent | Pamco Distributing, Inc. | accessdata.fda.gov |
| August 20, 2020 | K193578 | Non-spermicidal Lubricated Male Latex Condom | HIS | Substantially Equivalent | Global Protection Corp. | accessdata.fda.gov |
| November 12, 2015 | K150743 | Water Based Personal Lubricant with Flavours | NUC | Substantially Equivalent | Karex Industries Sdn. Bhd. | accessdata.fda.gov |
| April 14, 2015 | K150072 | TheyFit Male Condom | HIS | Substantially Equivalent | Theyfit | accessdata.fda.gov |
| August 1, 2014 | K141059 | NATURAL RUBBER LATEX MALE CONDOMS | HIS | Substantially Equivalent | Karex Industries Sdn. Bhd. | accessdata.fda.gov |
| September 27, 2013 | K122219 | THEYFIT MALE CONDOM | HIS | Substantially Equivalent | Theyfit | accessdata.fda.gov |
| March 28, 2012 | K110690 | ONE PERSONAL LUBRICANT (SILICONE) | NUC | Substantially Equivalent | One | accessdata.fda.gov |
| February 1, 2012 | K110691 | ONE PERSONAL LUBRICANT (WATER BASED) | NUC | Substantially Equivalent | One | accessdata.fda.gov |
| December 7, 2011 | K113061 | LARGE/EXTRA LAGRE CONDOM | HIS | Substantially Equivalent | Karex Industries Sdn. Bhd. | accessdata.fda.gov |
| May 12, 2010 | K092586 | MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU | HIS | Substantially Equivalent | Innolatex (Thailand) Limited | accessdata.fda.gov |
| February 6, 2009 | K081886 | KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED | HIS | Substantially Equivalent | Karex Industries Sdn. Bhd. | accessdata.fda.gov |
| March 25, 2003 | K024324 | LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 | HIS | Substantially Equivalent | Global Protection Corp. | accessdata.fda.gov |
| August 19, 1999 | K991892 | TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR | HIS | Substantially Equivalent | Line One Laboratories | accessdata.fda.gov |
| February 19, 1999 | K990067 | SHEER GLYDE DAMS | MSC | Substantially Equivalent | Louise C. Myers | accessdata.fda.gov |
| November 20, 1997 | K960552 | KNIGHT LIGHT NONLUBRICATED CONDOM | HIS | Substantially Equivalent | Global Protection Corp. | accessdata.fda.gov |
| March 21, 1997 | K970633 | TUSTEX FLAVORED CONDOMS | HIS | Substantially Equivalent | Line One Laboratories | accessdata.fda.gov |
| February 14, 1997 | K964599 | TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR | HIS | Substantially Equivalent | Line One Laboratories | accessdata.fda.gov |
| February 14, 1997 | K964598 | TRUSTEX COLA FLAVORD CONDOM | HIS | Substantially Equivalent | Line One Laboratories | accessdata.fda.gov |
| February 13, 1997 | K964591 | TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR | HIS | Substantially Equivalent | Line One Laboratories | accessdata.fda.gov |
| July 15, 1996 | K946103 | TRUSTEX FLAVOR CONDON IN COLORS | HIS | Substantially Equivalent | Line One Laboratories & Trading Co. | accessdata.fda.gov |
| August 14, 1991 | K902772 | PLEASURE PLUS | HIS | Substantially Equivalent | Medimix Products, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 10, 2009 | P080002 | FC2 FEMALE CONDOM | MBU | 2 | June 23, 2017 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 11, 2007 | 45525 | Not yet classified | Terminated | Lubricated Latex Condom. Labeled in part: "COMING TOGETHER IN DC", Distributed by Global Protection Corp., #12 Channel Street, Boston, MA | Condoms fail the water leak test and package integrity | accessdata.fda.gov |
Compare with other makers
- All makers of Condom
- All makers of Lubricant, Personal
- All makers of Condom, Synthetic
- All makers of Polymer Patient Examination Glove
- All makers of Barrier, Std, Oral Sex
Updated August 8, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.