ASTM D3578-19 (2023) PDF

Full title and description

ASTM D3578-19(2023) — Standard Specification for Rubber Examination Gloves. This specification sets requirements for natural rubber (latex) examination gloves intended for medical examinations, diagnostic and therapeutic procedures, and handling contaminated medical material; it addresses glove types, physical and dimensional properties, freedom from holes, powder and protein content, and required test methods.

Abstract

This specification covers Type I and Type II natural rubber examination gloves (either-hand fit, paired by size), including sterile and nonsterile packaging. It defines requirements and test methods for sterility, freedom from holes, dimensions, tensile strength, ultimate elongation, stress at elongation, powder-free residue and powder amount, protein content and antigenic protein content, and accelerated aging performance.

General information

• Status: Active.
• Publication date: January 9, 2023 (designation D3578-19(2023)).
• Publisher: ASTM International.
• ICS / categories: 11.140 (Hospital equipment / medical gloves).
• Edition / version: D3578-19(2023) (also referenced as D3578-19R23 on ASTM listings; reaffirmation/maintenance activity shown in ASTM document records).
• Number of pages: 5.

Scope

The standard applies to natural rubber (latex) examination gloves used for medical examination and procedures and for handling contaminated medical materials. It provides specifications for gloves that fit either hand, for sizing and pairing, and for both packaged sterile and packaged or bulk nonsterile products. The document specifies the tests and acceptance criteria needed to verify physical properties, sterility (when applicable), freedom from holes, powder and protein content, and performance after accelerated aging.

Key topics and requirements

• Defines Type I and Type II natural rubber examination gloves and requirements for either-hand fit and paired sizing.
• Freedom-from-holes requirements and detection methods (leak testing / AQL considerations referenced via test methods).
• Physical and dimensional requirements (length, thickness, tensile strength, ultimate elongation, stress at specified elongation) and post‑aging performance limits.
• Requirements and test methods for powder (powder-free residue and powder amount) and for protein and antigenic protein content.
• Referenced test methods include ASTM tests for tension (D412), heat aging (D573), residual powder (D6124) and hole detection (D5151), among others.

Typical use and users

Used by medical device manufacturers, quality and compliance teams, test laboratories, hospital procurement departments, regulatory affairs professionals, and PPE specifiers to define and verify the physical and safety performance of natural rubber examination gloves for clinical and laboratory use.

Related standards

Commonly referenced companion and related standards include ASTM D3577 (rubber surgical gloves), ASTM D6319 (nitrile examination gloves), ASTM D6977 (polychloroprene examination gloves), ASTM D5250 (PVC gloves), ASTM D5151 (detection of holes in medical gloves), ASTM D412 (tension/tensile testing), ASTM D573 (heat aging), ASTM D6124 (residual powder), and international standards such as ISO 11193 (single‑use medical examination gloves) and EN 455 series. These standards are used together when specifying, testing, and certifying medical glove products.

Keywords

rubber examination gloves; natural rubber latex; Type I; Type II; powder-free; sterility; tensile strength; elongation; protein content; antigenic protein; D412; D5151; D6124; medical gloves; ASTM D3578.

FAQ

Q: What is this standard?

A: ASTM D3578-19(2023) is the ASTM International specification that defines requirements and test methods for natural rubber (latex) examination gloves used in medical examinations and related procedures.

Q: What does it cover?

A: It covers types of natural rubber examination gloves (either‑hand fit), dimensional and physical property requirements, sterility and freedom-from-holes criteria, powder and protein limits, and referenced test methods used to verify conformance.

Q: Who typically uses it?

A: Manufacturers, quality and testing laboratories, hospital procurement and clinical engineering, regulatory and compliance teams, and PPE specifiers use this standard to specify, test, and accept natural rubber examination gloves.

Q: Is it current or superseded?

A: The designation in current listings is ASTM D3578-19(2023) and the document is listed as active (ASTM record shows a 2023 maintenance/reaffirmation activity). Users should confirm the edition before purchase or application to ensure they reference the latest active version.

Q: Is it part of a series?

A: Yes — it is maintained by ASTM Committee D11 (medical devices / D11.40 subcommittee) and is part of a family of ASTM standards for medical gloves (for example D3577 for surgical gloves, D6319 for nitrile examination gloves, D6977 for polychloroprene gloves, plus related test methods).

Q: What are the key keywords?

A: Natural rubber latex, examination gloves, Type I, Type II, powder-free, sterility, tensile strength, elongation, protein content, hole detection, ASTM D3578.