(153 days)
Powder Free Polyethylene Examination Gloves, 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 subject device in this 510(k) Notification is Synthetic Polymer- polyethylene - Powder Free Examination Glove. The subject device is a patient examination glove made from Low Density Polyethylene material, Black Color, Powder free and non-sterile (Per 21 CFR 880.6250 - class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. The available sizes of the subject devices are Small, Medium, Large. X-Large & XX Large.
The provided text describes the acceptance criteria and the study that proves the device, Synthetic Polymer Glove - Polyethylene (Black), meets these criteria. The device is a non-sterile, disposable examination glove.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria | Reported Device Performance (Average Results) | Final Status |
|---|---|---|---|
| Sterility | - | Non-sterile (Small, Medium, Large, X Large, XX Large) | - |
| Freedom from hole (ASTM D5151-19) | AQL 2.5 Inspection Level G-1 | Pass (for all sizes) | Pass |
| Overall Length (mm) | Min 230mm | Small: 261.53, Medium: 260.1, Large: 260.08, X-Large: 259.8, XX-Large: 268.5 | Pass |
| Width (±10 mm) | Small: 80, Medium: 95, Large: 110, X-large: 120, XX-Large: 130 | Small: 86.30, Medium: 99.4, Large: 115.23, X-Large: 123.54, XX-Large: 134.5 | Pass |
| Thickness at Palm (mm) | Min 0.05 mm | 0.06 mm (for all sizes) | Pass |
| Thickness at Fingertip (mm) | Min 0.05 mm | 0.06 mm (for all sizes) | Pass |
| Physical Properties - Before Ageing | |||
| - Tensile strength (MPa) | 14 MPa, min. | Small: 18.6, Medium: 17.45, Large: 18.53, X Large: 17.4, XX Large: 18.69 | Pass |
| - Ultimate Elongation (%) | 500% min | Small: 653.43, Medium: 673.5, Large: 689.15, X Large: 636.56, XX Large: 645.83 | Pass |
| Physical Properties - After Accelerated Ageing | |||
| - Tensile strength (MPa) | 14 MPa, min. | Small: 17.8, Medium: 18.13, Large: 18.61, X Large: 18.3, XX Large: 18.34 | Pass |
| - Ultimate Elongation (%) | 400% min | Small: 645.18, Medium: 680.2, Large: 686.15, X Large: 614.58, XX Large: 636.87 | Pass |
| Powder-free Residue (ASTM D6124-06) | < 2.0 mg per glove | Not detected (for all sizes) | Pass |
| Test for In vitro cytotoxicity (ISO 10993-5) | Non-Cytotoxic | (Implicitly tested and meets criteria) | Pass |
| Test for irritation and Skin Sensitization (ISO 10993-10) | Non-Skin Sensitized | (Implicitly tested and meets criteria) | Pass |
| Tests for irritation (ISO 10993-23) | Non-Irritant | (Implicitly tested and meets criteria) | Pass |
2. Sample size used for the test set and the data provenance
The sample size is specified as "Avg. value of 13 pcs" for the dimensional and physical properties tests. The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in the provided document, but it is implied to be from the manufacturer's internal testing as part of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the tests relate to the physical and chemical properties of the glove, not a diagnostic or interpretive task requiring expert consensus on a "ground truth" derived from patient data. The "ground truth" here is the adherence to established ASTM and ISO standards for medical gloves.
4. Adjudication method for the test set
This is not applicable as the tests are objective measurements and laboratory analyses against predefined standards. There is no interpretive "test set" requiring adjudication by multiple readers/experts.
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
This is not applicable. The device is an examination glove, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is an examination glove, not an algorithm or software.
7. The type of ground truth used
The ground truth for the device's performance is established by objective measurements and laboratory analyses against internationally recognized standards for medical examination gloves. Specifically, the standards referenced are:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application) - for mechanical properties and dimensions.
- ASTM D5151-19 - for freedom from holes.
- ASTM D6124-06 - for powder residue.
- ISO 10993-5:2009 - for in vitro cytotoxicity.
- ISO 10993-10:2021 - for skin sensitization.
- ISO 10993-23:2021 - for irritation.
8. The sample size for the training set
This is not applicable. The device is a physical product (glove) and does not involve machine learning or AI models that require training sets.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 22, 2023
UR Industry SDN BHD % A.C. Thirumaran Official Correspondent Integrated Assessment Services Pvt Ltd No. 1919-1920. Building D3, Miniie Plaza, Shuixi Road, Chennai, Tamil Nadu 600040 India
Re: K222531
Trade/Device Name: Synthetic Polymer Glove - Polyethylene (Black) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: December 31, 2022 Received: January 3, 2023
Dear A.C. Thirumaran:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K222531
Device Name Synthetic Polymer Glove - Polyethylene (Black)
Indications for Use (Describe)
Powder Free Polyethylene Examination Gloves, 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
SYNTHETIC POLYMER GLOVE-POLYETHYLENE (BLACK)
Preparation Date: 31/12/2022
510k: K222531
1. Submitter:
Company Name: UR Industry Sdn. Bhd. Company Address: NO. 180, Jalan Murni 9, Taman, Perindustrian Murni, 81400 Senai, Johor Darul Takzim, Malaysia. Facility Registration Number: 3018161411 Contact person: Mr. Chua Song Han Managing Director
2. Name of the Device
Trade Name / Proprietary Name: Synthetic Polymer Glove- Polyethylene (Black) Device Common Name: Polyethylene Examination gloves. Device Classification Name: Non-Powdered Patient Examination Glove (21 CFR 880.6250). Device Class: Class I. Product Code: LZA
2. Official Correspondent
Mr. A.C. Thirumaran Integrated Assessment Services Private Limited No.1495, Manasarovar, 16th Main Road, Anna Nagar west, Chennai- 600040, India. Email: iasfda16@gmail.com
4. Identification of the Legally Marketed Device (Predicate Device):
510K: K210463 Submitter: Xuzhou Full Sun Medical Products Ltd Trade/Device Name: Thermoplastic Elastomer (TPE) Hybrid Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA
5. Device Description
The subject device in this 510(k) Notification is Synthetic Polymer- polyethylene - Powder Free Examination Glove. The subject device is a patient examination glove made from Low Density Polyethylene material, Black Color, Powder free and non-sterile (Per 21 CFR 880.6250 - class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. The available sizes of the subject devices are Small, Medium, Large. X-Large & XX Large.
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6. Intended use of the Device
Powder Free Polyethylene Examination Gloves, 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. It is for over-the-counter use.
7. Technological characteristics Comparison for the proposed and predicate devices
| Characteristics | Acceptance Criteria | Subject device:Synthetic Polymer Glove-polyethylene (Black)UR INDUSTRY SD BHD(Small/ Medium/ Large/Xlarge/XX Large)K222531 | Predicate DeviceThermoplastic Elastomer(TPE) Hybrid ExaminationGloveXuzhou Full Sun MedicalProducts Ltd.(Small/ Medium/ Large/Xlarge)K210463 | Remarks |
|---|---|---|---|---|
| Product Code | LZA | LZA | LZA | same |
| Intended use | A powder free patientexamination glove is adisposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner. The deviceis for over- the- counter use. | This powder free patientexamination glove is adisposable device intended formedical purposes that is wornon the examiner's hand toprevent contamination betweenpatient and examiner. Thedevice is for over- the- counteruse. | Thermoplastic Elastomer (TPE)Hybrid Examination Glove is anon-sterile disposable deviceintended for medical purposethat is worn on the examiner'shands or fingers to preventcontamination between patientand examine | same |
| Material used | Low Density Polyethylenematerial | Low Density Polyethylenematerial | Low Density Polyethylenematerial | same |
| Color | N/A | Black | Blue | Different |
| Sterility | Sterile/Non-sterile | Non sterile | Non sterile | same |
| Single use | Single use | Single use | Single use | same |
| Overall Length (mm) Min230mm | Avg. value of 13 pcs (mm)Small - 261.53Medium- 260.1Large- 260.08X-large- 259.8XX -Large - 268.5 | Complies with ASTM D6319-19230 mm min | same | |
| Dimensions | Width (±10 mm)Small - 80Medium- 95Large-110X-large-120XX -Large 130 | Avg. value of 13 pcs (mm)Small - 86.30Medium- 99.4Large-115.23X-large-123.54XX -Large 134.5 | Small - 104 ± 5 mmMedium- 107 ± 5 mmLarge-115 ± 5 mmX-large-123 ± 5 mm | Our product of allranges meets theASTM D6319dimensionalrequirement.Whereas, thepredicate device hasexceeded indimensionalrequirement ofASTM D6319 andclaims to haveadhered to theirInternal Standardand nature of thematerial. |
| Thickness at Palm (mm) Min;0.05 mm | Palm - 0.06 mm. | Palm - 0.05 mm min. | same | |
| Characteristics | Acceptance Criteria | Subject device:Synthetic Polymer Glove-polyethylene (Black)UR INDUSTRY SD BHD(Small/ Medium/ Large/Xlarge/XX Large)K222531 | Predicate DeviceThermoplastic Elastomer(TPE) Hybrid ExaminationGloveXuzhou Full Sun MedicalProducts Ltd.(Small/ Medium/ Large/Xlarge)K210463 | Remarks |
| Thickness at Finger Tip (mm)Min 0.05 mm | Finger - 0.06 mm. | Finger - 0.05 mm min | same | |
| PhysicalProperties -ASTM D412-16& ASTMD573-04 | Before Ageing - Tensilestrength = 14MPa, min. | Tensile Strength (MPa)Avg. value of 13 pcsSmall - 18.6Medium -17.45Large -18.53X Large -17.4XX Large 18.69 | Tensile Strength 14 MPa, min. | same |
| Before Ageing - Ultimateelongation = 500% | Avg. values of 13 pcsUltimate elongation (%)Small - 653.43Medium - 673.5Large - 689.15X Large - 636.56XX Large - 645.83 | Elongation: Before Aging: 500%min. | same | |
| After Ageing - Tensile strength= 14MPa, min. | Tensile Strength (MPa)Avg. values of 13 pcsSmall- 17.8Medium - 18.13Large - 18.61X Large - 18.3XX Large - 18.34 | After Aging: 14 MPa, min. | same | |
| After Ageing – Ultimateelongation = 400% | Avg. values of 13 pcsUltimate elongation (%)Small - 645.18Medium - 680.2Large - 686.15X Large - 614.58XX Large - 636.87 | After Aging: 400% min. | same | |
| Freedom frompinholes ASTMD5151-19 | AQL 2.5 Inspection Level G-1 | Free from Holes | Free from Holes | same |
| Residual PowderASTM D6124-06 | < 2.0 mg/pc | < 2mg per glove | < 2mg per glove | same |
| Bio- Compatibility | ISO 10993-23:2010 Biologicalevaluation of medical devices:Tests for irritation | Non-Skin irritant | Non-Skin irritant | same |
| ISO 10993-10:2021 Biologicalevaluation of medical devices -Part 10: Tests For skinsensitization | No contact sensitization | No contact sensitization | same | |
| ISO 10993-5:2009 Biologicalevaluation of medical devices -Part 5: Tests for in vitrocytotoxicity | No In Vitro cytotoxicity | No In Vitro cytotoxicity | Same |
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UR INDUSTRY SDN BHD Synthetic Polymer Glove- Polyethylene 510k Premarket submission- Traditional
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UR INDUSTRY SDN BHD Synthetic Polymer Glove- Polyethylene 510k Premarket submission- Traditional
8. Summary of non-clinical testing results
Iconic Nitrile Glove was tested and found in conformance with the following standards:
| ASTM D6319-19 | Standard Specification for Nitrile Examination Gloves for Medical Application |
|---|---|
| ISO 10993-5:2009 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-10:2021 | Biological evaluation on medical device Part 10: Test for Skin Sensitization |
| ISO 10993-23:2021 | Biological evaluation of medical devices Part 23: Tests for irritation |
| TestMethodology | Purpose | AcceptanceCriteria | Average Results | Finalstatus | ||||
|---|---|---|---|---|---|---|---|---|
| Sterility | - | SmallNonsterile | MediumNonsterile | LargeNonsterile | X LargeNonsterile | XX LargeNonsterile | - | |
| Freedomfrom hole -ASTMD5151-19 | AQL 2.5 | Pass | Pass | Pass | Pass | Pass | Pass | |
| Dimension -width,Length,Thickness | Overall Length(mm) Min230mm. | 261.53 | 260.1 | 260.08 | 259.8 | 268.5 | Pass | |
| Width (±10mm)Small - 80Medium- 95Large-110X-large-120XX -Large -130 | 86.30 | 99.4 | 115.23 | 123.54 | 134.5 | Pass | ||
| Thickness at Palm & fingertip Min: 0.05 mm | ||||||||
| Palm | 0.06 | 0.06 | 0.06 | 0.06 | 0.06 | Pass | ||
| Fingertip | 0.06 | 0.06 | 0.06 | 0.06 | 0.06 | Pass | ||
| a. Before Aging | ||||||||
| ASTM D6319-19 | Physicalpropertiesbefore aging,afteracceleratedaging | TensileStrength=14MPa, min. | 18.6 | 17.45 | 18.53 | 17.4 | 18.69 | Pass |
| UltimateElongation=500%min | 653.43 | 673.5 | 689.15 | 636.56 | 645.83 | Pass | ||
| b. After Accelerated Aging | ||||||||
| TensileStrength=14MPa, min. | 17.8 | 18.13 | 18.61 | 18.3 | 18.34 | Pass | ||
| UltimateElongation=400% min | 645.18 | 680.2 | 686.15 | 614.58 | 636.87 | Pass | ||
| Powder-freeResidueexceedsmaximum limit- ASTMD6124-06 | < 2.0 mg perglove | Notdetected | Notdetected | Notdetected | Notdetected | Notdetected | Pass | |
| ISO 10993-5 | Test for Invitrocytotoxicity | Non- Cytotoxic | Pass |
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UR INDUSTRY SDN BHD Synthetic Polymer Glove- Polyethylene 510k Premarket submission- Traditional
| ISO 10993-10 | Test forirritation andSkinSensitization | Non - SkinSensitized | Pass |
|---|---|---|---|
| ISO 10993-23 | Tests forirritation | Non-Irritant | Pass |
9. Summary of clinical Performance data
Not applicable - Clinical data was not used to assess performance of the subject device.
10. Conclusion
The Conclusion drawn from the non-Clinical test demonstrates that the subject device - Synthetic Polymer Glove- polyethylene (Black) is as safe, as effective, and performs as well as or better than the legally marketed Predicate device cleared under K210463.
§ 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.