(139 days)
Powder Free Polyethylene Examination Gloves,Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The U-MED Powder Free Polyethylene Examination Gloves,Blue Color are nonsterile disposable Patient examination glove. The gloves are made of translucent (clear), Low Density Polyethylene material and are powder free. The U-MED Powder Free Polyethylene Examination Gloves,Blue Color come in four sizes: Small, Medium, Large, X Large. The Powder Free Polyethylene Examination Gloves, Blue Color acts as a barrier to prevent contamination between patient and examiner. The physical and performance characteristics of the devices meets all requirements of ASTM D5250 and ASTM D5151.
The provided text describes the 510(k) premarket notification for U-MED Powder Free Polyethylene Examination Gloves, Blue Color. This is a medical device clearance submission, NOT a study proving the device meets acceptance criteria for an AI/ML algorithm. The document focuses on demonstrating substantial equivalence to a predicate device for examination gloves based on physical characteristics and performance standards.
Therefore, most of the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, expert adjudication, MRMC studies, or training sets is not applicable to this document.
However, I can extract the relevant "acceptance criteria" for this type of medical device (physical examination gloves) as described in the summary and how the device's performance was proven to meet these standards.
Here's a breakdown of the information that is applicable and the explanation of why other parts are not:
Acceptance Criteria and Device Performance for U-MED Powder Free Polyethylene Examination Gloves, Blue Color
This document describes the 510(k) premarket notification for a Class I medical device (patient examination glove). The "acceptance criteria" here refer to meeting established physical and performance standards for such gloves, not performance metrics for an AI/ML algorithm. The study described is a series of non-clinical tests to demonstrate conformity to these standards and substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM D5250-06 (Reapproved 2015) | |
| Length | $\ge$ 230mm | Passed (Implied by meeting standard) |
| Width (Small) | 80-90 mm | Passed (Implied by meeting standard) |
| Width (Medium) | 90-100mm | Passed (Implied by meeting standard) |
| Width (Large) | 100-110mm | Passed (Implied by meeting standard) |
| Width (X Large) | 110-120 mm | Passed (Implied by meeting standard) |
| Thickness Fingertip | $\ge$ 0.05mm | Passed (Implied by meeting standard) |
| Thickness Palm | $\ge$ 0.08mm | Passed (Implied by meeting standard) |
| Physical Properties | ASTM D5250-06 (Reapproved 2015) | |
| Tensile strength (Before & After aging) | $\ge$ 11MPa | Demonstrated more than 11MPa |
| Elongated rate (Before & After aging) | $\ge$ 300% | Demonstrated more than 300% |
| Freedom from pinholes | 21 CFR 800.20 Passed Standard Acceptance Criteria; ASTM D5250-06 (Reapproved 2015); ASTM D5151-06 (Reapproved 2015) | Passed (Implied by meeting standard) |
| Powder Residual | ASTM D5250-06 (Reapproved 2015) and D6124-06 (Reaffirmation 2011) | Demonstrated less than 2 mg/glove |
| Biocompatibility | ISO 10993-10: 2010-08-01 | |
| Primary Skin Irritation | Passes | Not a primary skin irritant (Under the conditions of the study) |
| Dermal sensitization | Passes | Not a skin sensitizer (Under the conditions of the study) |
2. Sample size used for the test set and the data provenance:
- The document does not specify exact sample sizes for each test (e.g., how many gloves were tested for tensile strength or pinholes). It generally states that "those verification tests of gloves were performed."
- Data Provenance: The tests were conducted by "qualified test centers." No specific country of origin for the testing data is explicitly mentioned beyond the applicant's address in China. The studies are non-clinical, essentially laboratory-based tests of physical properties, not human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device, and "ground truth" is established by adhering to established ASTM and ISO standards for physical and chemical properties testing, not through expert consensus on medical images or diagnoses. The "experts" would be the personnel at the qualified testing centers who perform these standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is not an AI/ML algorithm or a comparative study involving human readers, there is no need for an adjudication method. Test results are based on objective measurements against defined standards.
5. 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. This submission is for a physical medical device (examination gloves), not an AI-assisted diagnostic tool. No human reader studies (MRMC) were performed or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm. Performance is assessed through physical and chemical testing of the gloves themselves.
7. The type of ground truth used:
- Standardized Test Results / Objective Measurements: The "ground truth" for this device is based on objective measurements and adherence to internationally recognized consensus standards for medical gloves, such as ASTM D5250, ASTM D5151, ASTM D6124, 21 CFR 800.20 (for pinholes), and ISO 10993-10 (for biocompatibility). These standards define acceptable ranges or thresholds for various physical properties (e.g., dimensions, tensile strength, elongation, pinhole rates, powder residual) and biological responses (skin irritation, sensitization).
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. No training set exists for this type of submission.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring an abstract symbol. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
February 20, 2018
Jiangsu U-MED Rubber & Plastic Products Co.,Ltd. % Chu Xiaoan Official Correspondent Beijing Easylink CO., LTD Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang, Beijing, 100021 CN
Re: K173228
Trade/Device Name: U-MED Powder Free Polyethylene Examination Gloves,Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: September 22, 2017 Received: November 22, 2017
Dear Chu Xiaoan:
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.
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
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801); medical device 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K173228
Device Name
U-MED Powder Free Polyethylene Examination Gloves,Blue Color
Indications for Use (Describe)
Powder Free Polyethylene Examination Gloves,Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
| Type of Use (Select one or both, as applicable) | ❍Prescription Use (Part 21 CFR 801 Subpart D)❌Over-The-Counter Use (21 CFR 801 Subpart C) | ❍ Prescription Use (Part 21 CFR 801 Subpart D) | ❌ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| ❍ Prescription Use (Part 21 CFR 801 Subpart D) | ❌ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) Summary
"The assigned 510(k) number is: _________K173228
Premarket Notification [510(k)] Summary
Submitter: 1.0
| Submitter's name : | Jiangsu U-MED Rubber & Plastic ProductsCo.,Ltd. |
|---|---|
| Submitter's address : | Luzhuang Road,Suyu High-Tech Zone,SuqianCity,Jiangsu Province,223804,China. |
| Phone number : | 0086-512-81625988 |
| Fax number : | 0086-512-58455833 |
| Name of contact person: | Chen Ye |
| Date of preparation : | 2018-01-24 |
2.0 Name of the Device
| Device Name: | U-MED Powder Free PolyethyleneExamination Gloves,Blue Color |
|---|---|
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LZA |
3.0 Predicate device
| C2 Powder Free Polyethylene Examination Glove |
|---|
| AmerCare Inc. |
| K113639 |
| - |
| 21 CFR 880.6250 |
| LZA |
4.0 Device Description:
The U-MED Powder Free Polyethylene Examination Gloves,Blue Color are nonsterile disposable Patient examination glove. The gloves are made of translucent (clear), Low Density Polyethylene material and are powder free. The U-MED Powder Free Polyethylene Examination Gloves,Blue Color come in four sizes: Small, Medium, Large, X Large.
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The Powder Free Polyethylene Examination Gloves, Blue Color acts as a barrier to prevent contamination between patient and examiner. The physical and performance characteristics of the devices meets all requirements of ASTM D5250 and ASTM D5151.
5.0 Indication for use:
Powder Free Polyethylene Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6.0 Comparison table:
| Features & Description | Predicate Device | Subject Device | Result ofComparison |
|---|---|---|---|
| Company | AmerCare Inc. | Jiangsu U-MED Rubber & Plastic Products Co.,Ltd. | -- |
| 510(K) Number | K113639 | K173228 | -- |
| Product name | Powder Free Polyethylene Examination Glove | U-MED Powder Free Polyethylene Examination Gloves,Blue Color | Similar |
| Product Code | LZA | LZA | Same |
| Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large | Same |
| Indication for use | A powder-free ,no-sterile patient examination gloves is disposable device intended for ,medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Powder Free Polyethylene Examination Gloves,Blue Color 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. | Similar |
| Device Description and Specifications | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2015) | Same |
| Dimensions:Overall length, Width, Palm and Finger thickness | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2015) | Same |
| Physical PropertiesTensile Strength before aging/after aging | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2015) | Same |
| Ultimate Elongation before aging/after aging | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2015) | Same |
| Freedom from PinholesHoles | Holes at Inspection Level I AQL2.5 | Holes at Inspection Level I AQL2.5 | Same |
| Residual Powder | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2015) | Same |
| Materials used to fabricate the devices | Polyethylene | Polyethylene | Same |
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| Color | Translucent [clear] | Blue color | Different |
|---|---|---|---|
| Compare performancedata supportingsubstantial equivalence | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reaffirmation 2011) | MeetsASTM D5151-06(Reapproved 2015)ASTM D5250-06(Reapproved 2015)ASTM D6124-06(Reaffirmation 2011) | Same |
| Single Patient Use | Single Patient Use | Single Patient Use | Same |
| Biocompatibility | Under the conditions ofthis study, not an irritantand Under the conditionsof this study, not asensitizer.SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | Under the conditions ofthis study, not an irritantand Under the conditionsof this study, not asensitizer.SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10 Third Edition2010-08-01 | Same |
| Labeling for the legallymarketed device towhich substantialequivalence is claimed. | There are no speciallabeling claims and we donot claim our gloves ashypoallergenic on ourlabels.-Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot | There are no speciallabeling claims and we donot claim our gloves ashypoallergenic on ourlabels.-Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot | Same |
7.0 Summary of the Technological Characteristics of the Device:
Powder Free Polyethylene Examination Gloves, Blue Color are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard |
|---|---|
| ASTM D 5250-06(Reapproved 2015). | |
| Dimension | Length$\ge$ 230mm |
| Width | |
| Small 80-90 mm | |
| Medium 90-100mm | |
| Large 100-110mm | |
| X large 110-120 mm | |
| Thickness Fingertip $\ge$ 0.05mmPalm $\ge$ 0.08mm | |
| PhysicalProperties | ASTM D 5250-06(Reapproved 2015). |
| Tensile strength (Before & After aging) $\ge$ 11MPa | |
| Elongated rate (Before & After aging) $\ge$ 300% | |
| Freedom frompinholes | 21 CFR 800.20 Passed Standard Acceptance Criteria |
| ASTM D5250-06(Reapproved 2015) | |
| ASTM D5151-06(Reapproved 2015) | |
| PowderResidual | ASTM standard D 5250-06(Reapproved 2015).and D6124-06(Reaffirmation 2011) Meets <2mg/glove |
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| Biocompatibility | Primary Skin Irritation in rabbitsISO 10993-10: 2010-08-01 | PassesUnder the conditions of thestudy, the subject device is nota primary skin irritant. |
|---|---|---|
| Dermal sensitization in the guinea pigISO 10993-10: 2010-08-01 | PassesUnder the conditions of thestudy, the subject device is nota skin sensitizer. |
8.0 Non-Clinical Performance Data:
U-MED Powder Free Polyethylene Examination Gloves,Blue Color, meet requirements per ASTM D5250-06(Reapproved 2015), per ASTM D6124-06 Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10:2010-08-01.
Those verification tests of gloves were performed by qualified test centers according to the above standards and included dimensions, Tensile strength (Before & After aging) & Elongated rate (Before & After aging), powder residual, water leak testing, a n d biocompatibility.t. The overall results of the testing demonstrated that the subject glove passed testing performed according to ASTM D5250, Tensile strength (Before & After aging) was demonstrated more than 11MPa, Elongated rate (Before & After aging) was demonstrated more than 300%, powder residual was demonstrated less than 2 mg/device. The subject glove also did not raise any biocompatibility concerns when tested according to ISO 10993-5 and ISO 10993-10.The detail information for the non-clinical testing performed was shown on section 7.0 Summary of the Technological Characteristics of the Device.
Clinical Performance Data: 9.0
Clinical performance testing was not needed for this device.
10.0 Conclusion:
Based on the nonclinical tests data, it can be concluded that the U-MED Powder Free Polyethylene Examination Gloves,Blue Color is as safe, as effective, and performs as well as the predicate device, C2 Powder Free Polyethylene Examination Glove AmerCare Inc. K113639.
§ 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.