Data / Medical devices / United States / Caution Wear Corp.
Caution Wear Corp.: FDA-registered device maker in Nashua, NH, United States, 5 510(k) clearances
Caution Wear Corp. is registered with the FDA (registration 3004819929) in Nashua, NH, United States. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated November 9, 2001. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004819929
- Address
- 1 Chestnut ST Ste 3C, Nashua, NH, United States, 03060
- Owner or operator
- CAUTION WEAR CORP. (9066840)
- Roles
- Repackager or relabeler
- First device listed
- December 4, 2007
- Registered through
- 2026
- Brand names listed
- CautionWear Black Ice, CautionWear Classic, CautionWear Grande, CautionWear Iron Grip, CautionWear Mission-707, CautionWear PPE, CautionWear Wild Rose, L.A.Confidential Dark Desire and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 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 |
|---|---|---|---|---|---|---|
| November 9, 2001 | K012964 | 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| November 9, 2001 | K012962 | DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| November 9, 2001 | K012665 | ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| June 15, 2001 | K010919 | MALE NATURAL RUBBER LATEX CONDOM | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| December 19, 2000 | K002393 | NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
Compare with other makers
Updated November 9, 2001. 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.