---
title: "Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene su... — FDA record Z-0838-2022 | Is It on Recall"
description: "Transport company failed to stop at the border for required FDA inspection."
url: https://isitonrecall.com/recall/fda-device-z-0838-2022-gammex-non-latex-pi-green-pi-kare-skin-friendly-pi-technology-polyisoprene-surgical-gloves-7-1-2/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2 — FDA record Z-0838-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 19, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
- **Reason**: Transport company failed to stop at the border for required FDA inspection.
- **Classification**: Class II
- **Recalling firm**: Ansell Healthcare Products LLC
- **Quantity**: 74 cases
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0838-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0838-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Model Number: 20685275 UDI Code: 00884792385244 Lot Number: 2107481604 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Arizona](https://isitonrecall.com/state/arizona/)
- [California](https://isitonrecall.com/state/california/)
- [Nevada](https://isitonrecall.com/state/nevada/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Utah](https://isitonrecall.com/state/utah/)
- [Washington](https://isitonrecall.com/state/washington/)

## Dates in the source

- **Report date**: Apr 6, 2022
- **Recall initiation date**: Feb 19, 2022
- **Center classification date**: Mar 30, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0838-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Ansell Healthcare Products LLC records](https://isitonrecall.com/brand/ansell-healthcare-products-llc/)