When a continuous series of lots is considered, the quality level for the purposes of sampling inspection is the limit of a satisfactory process average

Non-sterile medical gloves, which may or may not be anatomically shaped, intended for conducting medical examinations, diagnostics and therapeutic procedures and for handling contaminated medical material

Extractable proteins are aqueous extractable proteins and polypeptides of different molecular weights, which are extracted in a buffer solution

Inspection whereby either the unit of the product is classified simply as conforming or non-conforming, or the number of non-conformities in the unit of the product is counted, with respect to a given requirement or set of requirements

The inspection level defines a relationship between lot size and sample size. Inspection is carried out for the purpose of certification and surveillance to ensure that SMG manufacturers are in full compliance with the requirements of the scheme. 

The number of lots of gloves to be inspected is calculated using the formula:

If the outcome is not an integer and the decimal is equivalent to more than 500,001 pieces of gloves, this will then constitute an additional lot; any lesser figure will be ignored

A collection of units of product from which a sample shall be drawn and inspected to determine conformance with the acceptability criteria, and which may differ from a collection of units designated as a lot for other purposes (e.g. production, shipment, etc.)

Number, or combination of numerals, symbols or letters given by a manufacturer to each lot of individually packaged gloves, to identify uniquely that lot, and from which it is possible to trace that lot through all stages of manufacture up to packaging

The number of units of gloves in a lot is called the lot size. Each lot typically contains two million pieces of gloves

Any water insoluble residue remaining on the glove after a manufacturing process

A sample consists of one or more units of products drawn from a lot, the units of the samples being selected at random without regard to their quality. The number of units of products in the sample is the sample size

A specific plan which indicates the number of units of product from each lot which are to be inspected (sample size or series of sample sizes) and the associated criteria for determining the acceptability of the lot (acceptance and rejection numbers)

The use of the glove for a single task before being discarded