The boiled wet glove over wet hand scenario described above was not without its
problems. It caused the skin to become macerated. As sterilization technology advanced,
it became necessary to find a lubricant that could withstand the rigors of the new
steam autoclave (sterilization process).
Donning Lubricant Agents
Club moss
Spores from the fern Lycopodium clavatum, or club moss, was one of the early lubricants
in use by approximately 1890. Club moss was sometimes combined with talc to provide
the powder necessary to ease the donning of latex gloves. With its use came early
reports of complications, including masses and adhesions.
Talcum powder
Talcum powder is a combination of magnesium silicate (chemically pure talc) with
calcium magnesium carbonate, calcium magnesium silicate, and sometimes other substances.
It is inexpensive but can behave like a foreign body, causing inflammation. A talc
foreign body microscopically appears flat and irregular in shape (Woods et al.,
1997). Early in its use, talc was also implicated in producing granulomas in tissue.
Despite the reports in the literature describing granuloma, adhesion, and inflammatory
response to talc, it took awhile before a suitable substitute could be found. Various
powders were experimented with, but they could not withstand the time and pressure
in the autoclave without clumping. Additionally, the removal of glove powders was
not a precaution practiced by the surgical team at that time.
Cornstarch
The search for a suitable powdered donning agent ensued. Experiments by Lee and
Lehman (1947) led to the discovery of a mixture of cornstarch, a powder treated
with epichlorhydrin, and other ingredients. Sold commercially as Bio-Sorb, it was
able to withstand the autoclave and was acceptable to the wearer. Animal experiments
established that this product was absorbed with little or no reaction (Woods et
al., 1997). As a result, cornstarch replaced other powdered donning agents. It was
not without its problems, however, and further experiments by Lee demonstrated that
even this compound produced a foreign body-like reaction.
Mold Release Agents
Talc and cornstarch have also been used in the glove manufacturing process in order
to remove the finished product from the dipping mold. Today, a release agent such
as calcium carbonate may be used. Cornstarch is not usually used because it dissolves
and disperses in the dipping solution. A powderfree coagulant can also be used.
Due to the continued reporting of talc complications, the American Society for Testing
and Materials (ASTM) specified in 1991 that the use of talc as a mold release agent
was to be discontinued.
There are three different points in the manufacturing process at which powder is
used:
- On the finished glove, and before packing, donning powder is applied to the inside
so that the wearer is able to put the glove on smoothly. The powder also acts to
absorb sweat from the hands of the wearer.
- Mold release agents make up the powder slurry that coats the glove former so that
the latex uniformly covers the former and the finished glove is able to be removed
from the former.
- On the finished glove, a powder may be used to keep the gloves from sticking together.
A cornstarch powder is used for powdered gloves, while a post-process wash is used
for powder-free gloves.
Today’s Powders
Today, gloving powders used for exam and surgical gloves must meet the United States
Pharmacoepia (USP) monograph for absorbable dusting powder, or must be shown to
be equivalent in terms of safety and effectiveness (Draft Medical Glove Guidance
Manual July 30, 1999). ASTM standards also apply.
U.S.P. absorbable dusting powder (ADP) cornstarch cross-linked with epichlorhydrin
or phosphorus oxychloride and no more than 2% magnesium oxide (to prevent caking
or turning to paste) is most often used as the donning powder in gloves for healthcare
use.
The following firms with New Drug Application (NDA) or Pre-market Approval Application
(PMA) for USP Absorbable Dusting Powder are listed on the FDA Web site within the
Medical Glove Guidance Manual:
Company & Trade Names
- Roquette America - Keoflo 7136 & Keoflo 7136p
- National Starch and Chemical - Absorb & Absorb-HP
- Grain Processing Corp. - Pure-Dent 6851
- Agrarn Starkegesellschaft - Agenasorb & m.b.H. 9020
- A.E. Staley Manufacturing - Mir-flo Starch
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Early Dates in History
1917 – First reported talc granuloma (Woods et al., 1997)
1933 – Post-op FB granuloma reported by Antopol found to contain Lycopodium
(Woods et al., 1997)
1935 – Erb reported 6 cases of Lycopodium granuloma (Woods et al., 1997)
1936 – Owen described peritoneal nodules from use of glove powder containing
talc (Woods et al., 1997)
1943 – Germany reported 50 instances of talc granuloma (Woods et al., 1997)
1947 – Roberts reported talc deposited in peritoneal cavity had migrated
to fallopian tubes causing 5 women to be sterile (Woods et al., 1997)
1952 – Talc powder replaced by Bio-Sorb (Woods et al., 1997)
1952 – Lehman and Wilder recommended washing glove powder off gloves before
use during surgery (Woods et al., 1997)
1955 – Sneierson and Woo found cornstarch responsible for wound granuloma
(Woods et al., 1997)
1960 – Myers reported “starch peritonitis” with replication of same in animal
models (Woods et al., 1997)
1960-1980 – Multiple reports from all over the world of cornstarch complications
involving larger studies series (Woods et al., 1997)
1973 – Jagel and Ellis found adhesion formation (Woods et al., 1997)
1976 – Cade and Ellis found peritoneal reaction (Woods et al., 1997)
1978 – Walker found inflammatory reaction (Woods et al., 1997)
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