# FDA recall Z-2036-2018

> **WRP Asia Pacific Sdn Bhd** · Class II · device recall initiated 2018-05-07.

## Product

AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free,  Size 6.5, Item No. 10112

## Reason for recall

Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in the U.S. Powder on natural rubber latex gloves can aerosolize latex allergens, resulting in sensitization to latex and allergic reactions. Additional risks of powdered gloves include severe airway inflammation, conjunctivitis, dyspnea, as well as granuloma and adhesion formation when exposed to internal tissue.

## Distribution

Distributors in AL, CA, OH, ID, KS, MN, NC, PA, TX.

## Key facts

- **Recall number:** Z-2036-2018
- **Recalling firm:** WRP Asia Pacific Sdn Bhd
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-07
- **Report date:** 2018-06-06
- **Termination date:** 2019-05-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sepang, N/A, Malaysia

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2036-2018

## Citation

> AI Analytics. FDA recall Z-2036-2018. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-2036-2018. Source: US FDA. Licensed CC0.

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