No Glove No Love
✅ Low Risk
FEI: 3004704695 • Montego Bay • JAMAICA
FEI Number
3004704695
Location
Montego Bay
Country
JAMAICAAddress
52 Jarrett St., , Montego Bay, , Jamaica
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/21/2009 | 85HISCONDOM | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is No Glove No Love's FDA import refusal history?
No Glove No Love (FEI: 3004704695) has 1 FDA import refusal record(s) in our database, spanning from 4/21/2009 to 4/21/2009.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. No Glove No Love's FEI number is 3004704695.
What types of violations has No Glove No Love received?
No Glove No Love has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about No Glove No Love come from?
All FDA import refusal data for No Glove No Love is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.