CLASS II Device recall · Reported 21 Nov 2012 · FDA Enforcement Report

Select Medical Products Vinyl Powder-Free Exam Gloves, Medium recalled

Gulf South Medical Supply is recalling Select Medical Products Vinyl Powder-Free Exam Gloves, Medium, distributed nationwide in the US. The recall was initiated on 20 Jun 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # (for both sizes) 030212BU216995995 Medium gloves are Model # 6370, Product # 802634 Large gloves are Model # 6371, Product # 80635.

Quantity recalled275 cases and 17 boxes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0295-2013
FDA event ID: 63603
Recalling firm: Gulf South Medical Supply, Jacksonville, FL
Classification: Class II
Status: Terminated
Recall initiated: 20 Jun 2012
FDA classified: 15 Nov 2012
Reported: 21 Nov 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Masks, Gloves & PPE

Timeline

20 Jun 2012	Recall initiated by company
15 Nov 2012	Classified by FDA	+148 days
21 Nov 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale.

Product as listed by the FDA

Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usage: Patient Examination.

Where it was distributed

Nationwide distribution: USA including states of: DE, KY, LA, MD, NJ, NY, PA, TX, VA, and WV.

Nationwide Delaware Kentucky Louisiana Maryland New Jersey New York Pennsylvania Texas Virginia West Virginia

Questions about this recall

Why was it recalled?

Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale.

Which lots are affected?

Lot # (for both sizes) 030212BU216995995 Medium gloves are Model # 6370, Product # 802634 Large gloves are Model # 6371, Product # 80635.

Where was it sold?

Nationwide distribution: USA including states of: DE, KY, LA, MD, NJ, NY, PA, TX, VA, and WV.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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