(128 days)
The examination glove is a disposuble device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Textured, White, Latex, Sterile Powder Free Examination Gloves with Protein labeling Claim (50µg/dm² or Less of Water Soluble Protein)
Here's an analysis based on the provided text, outlining the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Device Performance |
|---|---|---|
| Dimension | ASTM Standard D3578 | Meets |
| Physical Properties | ASTM Standard D3578 | Meets |
| Freedom from Pinholes | 21 CFR 800.20; ASTM D5151 | Meets |
| Powder Residual | ASTM Standard D6124 | Meets (values below 2mg of residual powder) |
| Protein Level | ASTM Standard D5712 | Meets (values below 50 mcg/gm) |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10 | Passes |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10 | Gloves do not display any potential for sensitization |
| Sterilization | Radiation dose of 25 kGy (implied as "Same" to predicate) | Radiation dose of 25 kGy (from predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for testing each characteristic. However, each standard (ASTM, ISO, 21 CFR) defines specific methodologies and sample sizes for their respective tests. For example, ASTM D5151 (Freedom from Pinholes) would specify a certain number of gloves to be tested.
The data provenance is not explicitly mentioned, but given the context of a 510(k) submission to the FDA, it is expected that the testing was conducted prospectively according to the listed standards. No information on country of origin for the data is provided, nor is it indicated if it's retrospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable (N/A) to this type of device (examination gloves). The "ground truth" for glove performance is established by objective measurements against harmonized standards (e.g., ASTM, ISO), not by expert consensus or interpretation of images/data. The tests are industrial and chemical, not interpretive.
4. Adjudication Method for the Test Set
This information is N/A for this device. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For objective measurements of physical, chemical, and biological properties, results are either within spec or not.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is N/A for this device. MRMC studies are used to evaluate the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. The device in question is a physical glove, not an AI system.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is N/A for this device. A "standalone study" typically refers to the performance of an AI algorithm independent of human interaction. The device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this device's performance is established by objective measurements against recognized national and international standards. These standards define the acceptable range or threshold for each characteristic (e.g., minimum elongation, maximum protein level, freedom from pinholes). There is no "expert consensus," "pathology," or "outcomes data" in the traditional sense for these performance criteria.
8. The Sample Size for the Training Set
This information is N/A for this device. The concept of a "training set" (used to train machine learning models) is not relevant to the evaluation of physical medical devices like examination gloves. Development of such gloves involves manufacturing processes and quality control, not AI model training.
9. How the Ground Truth for the Training Set Was Established
This information is N/A for this device, for the same reasons as point 8.
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Abbreviated 510(k) Premarket Notification Latex Sterile Powder Free Examination Gloves Section 5, 510(k) Summary Page 1 of 3
| 5. | 510(k) SUMMARY | K122788 | ||
|---|---|---|---|---|
| DATE: | February 17, 2012 | |||
| OWNER: | Northstar Healthcare Holdings70 Sir John Rogerson's QuayDublin 2, Ireland | JAN 17 2013 | ||
| OFFICIAL CORRESPONDENT: | Michael RiordanOperations ManagerTelephone: 00353-21-4548255Fax: 00353-21-4548294Email: michael.riordan@mckesson.ie | |||
| DEVICE NAME: | Trade Name: | Textured, White, Latex, Sterile Powder FreeExamination Gloves with Protein labeling Claim(50µg/dm² or Less of Water Soluble Protein) | ||
| Common Name: | Patient Examination Gloves | |||
| Classification: | Patient Examination Gloves | |||
| Class: | Class I | |||
| Product Code: | LYY |
PREDICATE DEVICE(S):
| Predicate510(k) | Device Name | Indication | ClearanceDate | Company |
|---|---|---|---|---|
| K090327 | Powder Free PolymerCoated LatexExamination Gloves,Sterile, with Proteinlabeling Claim(50 $ μ $ g/dm² or Less ofWater Soluble Protein) | A powder free polymer coated latexexamination glove is a disposable devicemade of natural rubber material intended tobe worn on the hand for medical purposes toprovide barrier against potentially infectiousmaterials and other contaminants. | 03 Apr 2009 | Wear Safe SDN,BHD |
DEVICE DESCRIPTION: Textured, White, Latex, Sterile Powder Free Examination Gloves with Protein labeling Claim (50μg/dm² or Less of Water Soluble Protein)
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STATEMENT OF INTENDED USE:
The Textured, White, Latex, Sterile Powder Free Examination Gloves with Protein labeling Claim (50ug/dm² or Less of Water Soluble Protein) is a Disposable device intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.
TECHNOLOGICAL CHARACTERISTICS:
The Textured, White, Latex, Sterile Powder Free Examination Gloves with Protein labeling Claim (50µg/dm² or Less of Water Soluble Protein) is substantially equivalent to the predicate device with regard to physical characteristics, design, product features, and intended use. Both gloves are made with latex using similar manufacturing processes.
| Feature | Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein labeling Claim (50µg/dm² or Less of Water Soluble Protein) K090327 Predicate | Textured, White, Latex, Sterile Powder Free Examination Gloves with Protein labeling Claim (50µg/dm² or Less of Water Soluble Protein) (Proposed) |
|---|---|---|
| Intended Use | Intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | Same |
| Indications for Use Statement | A powder free polymer coated latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants. | The sterile latex examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. |
| Description | Sterile, powder free, examination gloves made of latex. The gloves are provided in sizes small, medium, and large. | Same |
| Presentation | Sterile gloves are provided in dispenser boxes. | Same |
| Color | White | White |
| Material | Latex | Same |
| Sterilization | Sterile | Same |
| Single Use | Yes | Same |
| Dimensions | Meets ASTM D3578-05 | Length Small 220mm min.Medium, Large 230 mm min.Width Small 80-90mmMedium 90-100mmLarge 101-111mmThickness Finger 0.13 mm min.Palm 0.11 mm min. |
| Physical Properties | Meets ASTM D3578-05 | Before aging/after agingElongation 650% 500%Tensile Strength 18MPa 14MPa |
| Freedom from Pinholes | Meets ASTM D5151-06 | Same |
| Residual Powder | Meets ASTM D6124-06 | Same |
| Protein Level | Meets ASTM D5712-10 | Same |
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| BiocompatibilityTests | Passes Primary Skin Irritation in RabbitsPasses Guinea Pig Maximization | SameSame |
|---|---|---|
| Sterilization | Radiation dose of 25 kGy. | Same |
ASSESSMENT OF NONCLINICAL DATA:
| Characteristic | Standard | DevicePerformance |
|---|---|---|
| Dimension | ASTM Standard D3578 | Meets |
| Physical Properties | ASTM Standard D3578 | Meets |
| Freedom from Pinholes | 21 CFR 800.20; ASTMD5151 | Meets |
| Powder Residual | ASTM Standard D6124 | MeetsResults generatedvalues below 2mgof residualpowder |
| Protein Level | ASTM Standard D5712 | MeetsResults generatedvalues below 50mcg/gm |
| Biocompatibility | Primary Skin Irritationin rabbits(ISO 10993-10) | |
| Dermal Sensitization inthe guinea pig (ISO10993-10) | Gloves do notdisplay anypotential forsensitization |
CONCLUSIONS:
The Latex Sterile Powder Free Examination Gloves meet the requirements of established standards ASTM D3578-05, ASTM D5712-10, ASTM D5151-06, ASTM D6124-06 and ISO 10993-10.
Based on the comparison of intended use, design, materials and performance, the Latex Sterile Powder Free Examination Gloves are substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract symbol to the right and text arranged in a circular fashion to the left. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
January 17, 2013
Northstar Healthcare Holdings C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, IL 60062
Re: K122788
Trade/Device Name: Textured, White, Latex, Sterile Powder Free Examination Gloves with Protein Labeling Claim (50ug/dm2 or Less of Water Soluble Protein) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: November 27, 2012 Received: January 4, 2013
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Devine
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Clinton D. Annett
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K122788
Device Name:
Textured, White, Latex, Sterile Powder Free Examination Gloves with Protein labeling Claim (50µg/dm² or Less of Water Soluble Protein)
Indications for Usc: The examination glove is a disposuble device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
AND/OR
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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Concur valuation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 188 510(k) Number:
Page Tot 1
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.