Product Information Sheet: Patient Examination Gloves

Patient Examination GlovesProduct Information

Product description: Patient examination gloves (21 CFR 880.6250)

Product group: Personal Protective Equipment

Demand

Usage guidance: Single use, hand hygiene and proper don/doff are critical

Current availability: Moderate

Manufacturing

Technologies required to manufacture: Chemicals (co-polymerization, monomers, plasticizers, Calcium Carbonate/Nitrate baths), rubber molding, ceramic molds, vulcanization, chlorination

Degree of automation: Fully automated by large players, but for smaller players stripping ceramic molds typically done manually

Regulatory & compliance validation process difficulty: Low

FDA Classification: Class I – 510(k) exempt

Raw material availability: Uncured nitrile, natural rubber, chemicals, polymers likely available

Design Requirements1

  • Examination gloves (non surgical / non sterile, unless for medical intervention)
  • Disposable, thin (3mm), common sizes: S, M, L (M, L typically sufficient)
  • Nitrile (unpowdered with finishing to remove chemicals is most common), Latex / natural rubber, polychloroprene
  • Unpowdered (mandatory if latex2) or powdered (good for use on wet hands); if unpowdered, then finished with chlorination or polymer coating (improves donning and doffing, and reduces the allergen content in latex gloves)
  • Length: ideally long cuffs up to mid-forearm (not mandated by CDC currently)
  • Double-gloving not mandated by CDC for COVID-19 care

Standards:

  • ASTM D6319, D3578, D5250, D6977 or equivalent

Based on Acceptable Quality Limits (AQL) set by the FDA

  • Tensile strength
  • Elongation
  • Leak test

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1. CDC PPE COVID19 guidance (23 Mar 2020)

2. FDA prohibits powder with Latex gloves because of concerns on impairing wound healing

Source: Derived from manufacturing expert interviews; image courtesy of Cardinal Health

WORKING DOCUMENT, SUBJECT TO CHANGE. NOT EXHAUSTIVE.

DOCUMENT INTENDED TO PROVIDE INSIGHT BASED ON CURRENTLY AVAILABLE INFORMATION FOR CONSIDERATION AND NOT SPECIFIC ADVICE.