(76 days)
A powder-free surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
The gloves are made of polyisoprene synthetic latex and green colored. They are washed with Ammonia solution to leach off mold release powder, chemical and protein before they are chlorinated and inner coated with the solution of coating material for ease of donning. The gloves are tested for pinhole by water leak test machine. They are sterilized by gamma irradiation.
Here's an analysis of the acceptance criteria and supporting studies for the Medigloves® Sterile Powder-free Synthetic Polyisoprene Surgical Gloves:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Dimensions (ASTM D3577-01a22) | Meets ASTM D3577-01a22 |
| Physical Properties (ASTM D3577-01a22) | Meets ASTM D3577-01a22 |
| Freedom from pinholes (ASTM D3577-01a22) | Meets ASTM D3577-01a22 |
| Freedom from pinholes (ASTM D5151-99) | Meets ASTM D5151-99 |
| Powder-Free (ASTM D6124-01) | Meets ASTM D6124-01 (2 mg/glove maximum) |
| Sterility (ASTM D3577-01a82) | Meets ASTM D3577-01a82 |
| Primary irritation | No irritation (tested in rabbits) |
| Sensitization | No sensitization (tested in mice) |
Study Details
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Sample size used for the test set and the data provenance:
The document does not specify the exact sample size for each test condition. However, it indicates that testing was performed according to established ASTM standards (D3577-01a22, D5151-99, D6124-01, D3577-01a82) for physical properties, pinholes, powder content, and sterility. These standards inherently define the minimum sample sizes and methodologies for testing.
The primary irritation and sensitization testing were conducted on rabbits and mice, respectively. No specific numbers of animals are provided.
The data provenance is from nonclinical laboratory and animal data, indicating controlled studies rather than human data. The geographical origin of these studies is not explicitly stated, but the manufacturer is based in Thailand. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable (N/A). The "ground truth" for the performance criteria is established by adherence to recognized international standards (ASTM) for glove manufacturing and testing, and by established protocols for biocompatibility testing in animal models. This does not involve human expert consensus in the same way clinical diagnostic studies would. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable (N/A). Performance against pre-defined engineering and biological standards does not typically involve human adjudication in the same manner as clinical interpretation. The tests yield objective measurements or observations (e.g., pass/fail for pinholes, measured powder levels, observed irritation reactions). -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable (N/A). This device is a surgical glove, not a diagnostic imaging or AI-assisted device. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable (N/A). This device is a physical product, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth is based on:- Adherence to recognized industry standards: ASTM (American Society for Testing and Materials) specifications for physical properties, pinholes, powder content, and sterility. These standards define measurable thresholds for acceptable performance.
- Biological responses: Observed reactions (or lack thereof) in animal models for primary irritation and sensitization.
-
The sample size for the training set:
Not applicable (N/A). This device is not an AI/machine learning model, so there is no concept of a "training set." -
How the ground truth for the training set was established:
Not applicable (N/A). As there is no training set, this question is not relevant.
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APR 1 3 2005
Section E - 1 - 510(k) Summary
Medigloves Ltd. Submitters Name :
Submitter's Address : 33/3 Moo 2 Tivanont Road Amphur Muang Pathumtani 12000 Thailand
Submitter's Phone Number : +662 501 2141-5
Submitter's Fax Number : +662 501 2146-7
Name of Contact Person : Mr. Worasak Wongprakornkul
Date of Preparation : January 19, 2005
Trade Name of Device : Medigloves® Sterile Powder-free Synthetic Polyisoprene Surgical Gloves
Device Name : Medigloves® Sterile Green Powder-free Synthetic Polyisoprene Surgical Gloves (Green)
Common Name : Surgical Gloves
Classification Name : Surgeon's gloves, powder-free (per proposed § 878.4461)
Legally Marketed Device to Which Equivalency is Being Claimed :
Medigloves® Sterile Powder-free Synthetic Polyisoprene Surgical Gloves as described in this 510(k) notification are substantially equivalent to:
ESTEEM® Sterile Polyisoprene Surgical Gloves (K011721) Sterile SensiCare™ Synthetic Polyisoprene Powder-Free Surgical Gloves (K002933) BarrierPlus® Powder-Free Synthetic Polyisoprene Surgical Gloves (K990710)
The difference is that Medigloves' gloves has green color but the safety and effectiveness of the device is maintained.
Description of the Device:
The gloves are made of polyisoprene synthetic latex and green colored. They are washed with Ammonia solution to leach off mold release powder, chemical and protein before they are chlorinated and inner coated with the solution of coating material for ease of donning. The gloves are tested for pinhole by water leak test machine. They are sterilized by gamma irradiation.
Medigloves® Sterile Powder-free Synthetic Polyisoprene Surgical Gloves meet the description of Rubber Surgical Gloves as described in ASTM D 3577-01a24, type 2 rubber surgical gloves.
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Section E - 2 - 510(k) Summary (continued)
Intended Use of the Device:
Medigloves® Sterile Powder-free Synthetic Polyisoprene Surgical Gloves is a disposable device made of synthetic material that may bear trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contamination.
Summary of Technological Characteristics Compared to the Predicate Device:
Medigloves® Sterile Powder-free Synthetic Polyisoprene Latex Surgical Gloves posses the following technological characteristics (as compared to ASTM or equivalent standards).
Dimensions : Meets ASTM D3577-01a22
Physical Properties : Meets ASTM D3577-01a22
Freedom from pinholes : Meets ASTM D3577-01a22 Meets ASTM D5151-99
Powder-Free : Meets ASTM D6124-01 2 mg/glove maximum
Sterility : Meets ASTM D3577-01a82
Brief Discussion of Nonclinical Tests :
Primary irritation testing in the rabbits and sensitization testing on the mice indicate no irritation or sensitization.
Brief Discussion of Clinical Tests :
Clinical data are not needed for surgical gloves.
Conclusions Drawn for the Nonclinical and Clinical Tests :
Nonclinical laboratory and animal data indicate that Medigloves® Sterile Powder-free Synthetic Polyisoprene Surgical Gloves meets all performance and biocompatibility requirements.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
APR 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medigloves Limited C/O Mr. Kobby Dankwah Medigloves Representative Westminster Capital, Incorporated 9665 Wilshire Boulevard, Suite M-10 Beverly Hills, California 90212
Re: K050181
Trade/Device Name: Medigloves® Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves (Green) Regulation Number: 878.4460 Regulation Name: 878.4460 Regulatory Class: II Product Code: KGO Dated: January 26, 2005 Received: January 31, 2005
Dear Mr. Dankwah:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your betermined the device is substantially equivalent (for the itelerenced above and nave actecinclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce pror to that have been reclassified in accordance with the provisions of Amendinens, of to devices that have oost (Act) that do not require approval of a premarket the rederal Pood, Drug, and Conners , therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the Fist. Food, listing of devices, good manufacturing practice, requirements for sibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (PMA), it may oc subject to such adata and Regulations, Title 21, Parts 800 to 898. In your device can be found in the South no mouncements concerning your device in the Federal Register.
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Page 2 -Mr. Dankwah
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that 1 DTC s lestainer on that your device complies with other requirements mean that FDA nas made a deceminations administered by other Federal agencies. of the Act of ally I ederal statutes and registments, including, but not limited to: registration 1 ou must comply with an the Pieceling (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 807), labeling (21 CFR Part 820); and if requirents as set form in the quality special (S) (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mainerally your device of your device to a premarket notification. - The PD results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at rio to for your at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of 0101638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chris
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Section D-1 – Statement of Indications for Use | ||
|---|---|---|
| Indications for Use | ||
| 510(k) Number (if known) : | K050181 | |
| Device Name : | Medigloves ® Sterile Powder-free Synthetic Polyisoprene Surgical Gloves (Green) | |
| Indications For Use: | A powder-free surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. | |
| Sheila P. Magilay (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | ||
| 510(k) Number: | K050181 | |
| Prescription Use (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).