(76 days)
Not Found
No
The summary describes a surgical glove and its manufacturing process, with no mention of AI or ML technology.
No
A powder-free surgeon's glove is described as a barrier against potentially infectious materials and contaminants, which is not a therapeutic function.
No
Explanation: The device is described as a "powder-free surgeon's glove" intended to provide a barrier against contaminants, which is a protective function, not a diagnostic one. There is no mention of it being used to identify or analyze diseases or conditions.
No
The device is a physical medical device (surgical gloves) and does not describe any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "powder-free surgeon's glove... intended to be worn on the hands... to provide a barrier against potentially infectious materials and other contaminants." This describes a physical barrier device used for protection, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the material, manufacturing process, and testing for physical integrity (pinhole test). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological specimens, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
KGO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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.
2
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.
3
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
4
.
| 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)
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