(233 days)
Pro Guard ® Nitrile Powder free Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Black Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21 CFR 880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are black in color and are powder free.
The provided document is a 510(k) summary for a medical device: "Pro Guard® Nitrile Powder Free Examination Glove." This type of document is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not typically a study proving the efficacy or performance of a new medical AI device.
Therefore, the requested information regarding acceptance criteria and study design for an AI device (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable to this document.
The document discusses the performance of a physical medical device (gloves) against established standards for physical properties and biocompatibility.
Here's the relevant information extracted from the provided text, structured to best fit the spirit of your request, but acknowledging the difference in device type:
Device: Pro Guard® Nitrile Powder Free Examination Glove
Device Type: Class I, reserved Non-powdered patient examination glove
1. Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance* | Status |
|---|---|---|---|---|
| Dimension | ||||
| Length | ASTM D6319-19 | Min 230 mm for all sizes | Extra Small: min 240 mm; Small: min 243 mm; Medium: min 241 mm; Large: min 240 mm; Extra Large: min 240 mm | Pass |
| Width | ASTM D6319-19 | XS: 70±10 mm; S: 80±10 mm; M: 95±10 mm; L: 110±10 mm; XL: 120±10 mm | XS: 75 mm; S: 85 mm; M: 95 mm; L: 105 mm; XL: 115 mm | Pass |
| Thickness (Palm) | ASTM D6319-19 | 0.05 mm min for all sizes | XS, S, M, L, XL: 0.09 mm | Pass |
| Thickness (Finger) | ASTM D6319-19 | 0.05 mm min for all sizes | XS: 0.12 mm; S: 0.13 mm; M: 0.12 mm; L: 0.12 mm; XL: 0.12 mm | Pass |
| Watertight Test | ASTM D5151-19 | Sample size: 200 pcs; Inspection level: GI; AQL 1.5; Acceptance Number: 7; Rejection Number: 8 | 0 (Zero) defects for all sizes (Extra Small, Small, Medium, Large, Extra Large) | Pass |
| Residual Powder | ASTM D6124-06 (Reapproved 2017) | 2 mg per glove or less | XS: 1.35 mg/glove; S: 1.42 mg/glove; M: 1.24 mg/glove; L: 1.34 mg/glove; XL: 1.36 mg/glove | Pass |
| Physical Properties: Tensile Strength | ||||
| Before Aging | ASTM D6319-19 | 14 MPa min for all sizes | XS: 18.08 MPa; S: 18.37 MPa; M: 24.56 MPa; L: 18.30 MPa; XL: 18.20 MPa | Pass |
| After Aging | ASTM D6319-19 | 14 MPa min for all sizes | XS: 14.01 MPa; S: 14.08 MPa; M: 20.41 MPa; L: 14.00 MPa; XL: 14.00 MPa | Pass |
| Physical Properties: Ultimate Elongation | ||||
| Before Aging | ASTM D6319-19 | 500% Min for all sizes | XS: 611 %; S: 612%; M: 645 %; L: 620%; XL: 587% | Pass |
| After Aging | ASTM D6319-19 | 400% Min for all sizes | XS: 412 %; S: 408%; M: 584%; L: 403%; XL: 416% | Pass |
| Biocompatibility | ||||
| Primary Skin Irritation | ISO 10993-10 Third Edition 2010-08-01 | Not an irritant | Under the conditions of the study, not an irritant | Same |
| Dermal Sensitization | ISO 10993-10 Third Edition 2010-08-01 | Not a sensitizer | Under the conditions of the study, not a sensitizer | Same |
| In vitro cytotoxicity | ISO10993-5:2009(E) | Not applicable (predicate had no data) - New device showed cytotoxicity at high concentrations, but non-cytotoxic at 1:16 and 1:32. | Under the conditions of the study, cytotoxic for undiluted, 1:2, 1:4 and 1:8 dilutions, but non-cytotoxic for 1:16 and 1:32 dilutions. | Different (but deemed acceptable) |
| Acute Systemic Toxicity | ISO10993-11:2017(E) | Not applicable (predicate had no data) - New device showed no systemic toxicity. | Under the conditions of the study, did not induce any systemic toxicity. | Different (but deemed acceptable) |
*The "Reported Device Performance" column directly reflects the "Result" column from the provided 510(k) summary (page 7).
The following points are not applicable to this 510(k) submission for a physical medical glove. They typically pertain to AI/machine learning medical devices.
- 2. Sample sizes for test set and data provenance: Non-clinical physical tests are described, not AI model testing. The sample sizes for each test are listed next to the "Acceptance Criteria," e.g., 200 pieces for watertight test, 5 pieces for residual powder. The data provenance is implied to be from the manufacturer's own testing in Thailand.
- 3. Number of experts used to establish ground truth & qualifications: Ground truth for physical properties is established by objective measurements against international standards (ASTM, ISO), not by expert consensus in the way an AI medical imaging task would require.
- 4. Adjudication method: Not applicable as it's not an AI performance study requiring human interpretation.
- 5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is for evaluating changes in human reader performance with AI assistance.
- 6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. This is a physical device, not an algorithm.
- 7. Type of ground truth used: For physical properties, the ground truth is objective measurement against specified standards (e.g., length in mm, thickness in mm, tensile strength in MPa, number of holes). For biocompatibility, it's based on standardized biological tests.
- 8. Sample size for the training set: Not applicable. This is not an AI/ML device that requires training data.
- 9. How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an abstract design. To the right of the seal, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font. The logo is simple and professional, and it is easily recognizable.
August 6, 2022
Medical Glove Co., Ltd Teoh Choh Shee Managing Director 288, Moo 7, Tambon Lam Thap, Krabi 81190 Thailand
Re: K213934
Trade/Device Name: Pro Guard Nitrile Powder Free Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 17, 2022 Received: June 30, 2022
Dear Teoh Choh Shee:
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.
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
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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 medical devices and radiation-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 Oian, 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 Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K213934
Device Name
Pro Guard® Nitrile Powder Free Examination Glove
Indications for Use (Describe)
Pro Guard ® Nitrile Powder free Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand 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)
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Image /page/3/Picture/0 description: The image shows the logo for "MG Medical Glove". The letters "MG" are large and bolded on the left side of the image. To the right of the letters is the text "Medical Glove".
510(k) SUMMARY (K213934) Nitrile Powder Free Examination Gloves
1.0 Submitter:
| Applicant: | Medical Glove Co., Ltd.288, Moo 7, Tambon Lam Thap,Amphur Lam Thap, Krabi 81190, Thailand |
|---|---|
| Phone Number: | +66 98 0166138 |
| Fax Number: | +66 75 626500 |
| Name of Contact Person: | Teoh Choh Shee (Mr.) |
| Preparation date: | July 19, 2022 |
2.0 Identification of the subjected device:
| Trade/Proprietary Name(s): | Pro Guard® Nitrile Powder Free Examination Glove. |
|---|---|
| Common Name: | Nitrile Powder Free Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Device Classification: | I |
| Product code | LZA |
| Regulation Number: | 21 CFR 880.6250 |
3.0 Predicate Device:
| Device Name: | Powder Free Nitrile Patient Examination Glove, Black Colored,Non-Sterile. |
|---|---|
| 510(k): | K143131 |
| Common Name: | Patient Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Device Classification: | I |
| Product Code: | LZA |
| Regulation Number: | 21 CFR 880.6250 |
4.0 Description of the Device:
Black Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21 CFR 880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are black in color and are powder free.
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Image /page/4/Picture/0 description: The image shows the logo for MG Medical Glove. The letters "MG" are in large, bold, yellow font on the left side of the image. To the right of the letters, the words "MEDICAL GLOVE" are stacked on top of each other, also in yellow font.
5.0 Indication for Use:
Pro Guard® Nitrile Powder Free Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
6.0 Summary of Technological Characteristics of the Device Compared to the Predicate Device:
| Characteristics | Standards | Device performance | Comparison | |
|---|---|---|---|---|
| Predicate | Current (K213934) | |||
| 510(k) Number | - | K143131 | New 510(k) submission | Not Available |
| Manufacturer(s) | - | Kossan International Sdn. Bhd | Medical Glove Co., Ltd | ---- |
| Indication for Use | Medical Gloves Guidance Manual - Issued on January 22, 2008 | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner | Pro Guard® Nitrile Powder free Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | Similar |
| Design Material | ASTM D6319-19 | Nitrile | Nitrile | Same |
| Color | - | Black | Black | Same |
| Design | - | Ambidextrous, in different sizes per ASTM D6319 dimension requirement | Ambidextrous, in different sizes per ASTM D6319 dimension requirement | Same |
| Device Classification | - | Class I | Class I | Same |
| Shelf life | - | No data is available | 3 years | Different |
| Size | ASTM D6319-19 | Extra SmallSmallMediumLargeExtra LargeXX-Large | Extra SmallSmallMediumLargeExtra Large | Different |
| Single Use | Medical Gloves Guidance Manual - Issued on January 22, 2008 | Single use | Single use | Same |
| Sterility | - | Non-sterile | Non-sterile | Same |
| Characteristics | Standards | Device performance | Comparison | |
| Predicate | Current (K213934) | |||
| Dimension | ASTM D6319-19 | Length$\ge$ 230 mm minimum | Length230 mm min | Similar |
| Width | Width | |||
| X-Small 70-80 mm | Extra Small: 70 + 10 mm | |||
| Small 80-90 mm | Small: 80 + 10 mm | |||
| Medium 90-100 mm | Medium: 95 ± 10 mm | |||
| Large 101-111 mm | Large: 110± 10 mmExtra Large: 120 ± 10 mm | |||
| X-Large 111-121 mm | ||||
| XX-Large 121-131 mm | ||||
| Thickness | ASTM D6319-19 | Finger: 0.05 mm minPalm: 0.05 mm min | Finger: 0.05 mm minPalm: 0.05 mm min | Same |
| PhysicalProperties | ASTM D6319-19 | Before aging | Before aging | Same |
| Tensile Strength: | Tensile Strength: | |||
| 14 MPa min | 14 MPa min | |||
| Ultimate Elongation:500% min | Ultimate Elongation:500% min | |||
| After aging | After aging | |||
| Tensile Strength14 MPa min | Tensile Strength14 MPa min | |||
| Ultimate Elongation:400% min | Ultimate Elongation:400% min | |||
| Watertight test(1000 ml) | ASTM D5151-19 | Pass AQL 1.5 | Pass AQL 1.5 | Same |
| Powder Residue | ASTM D6124-06(Reapproved 2017) | $\le$ 2.0 mg/glove | $\le$ 2.0 mg/glove | Similar |
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Image /page/5/Picture/0 description: The image shows the words "MG MEDICAL GLOVE" in a yellow font. The letters "MG" are larger than the other words. The words "MEDICAL GLOVE" are stacked on top of each other. The background is white.
MEDICAL GLOVE CO., LTD
288 Moo 7 T. Lam Thap, A. Lam Thap, Krabi 81190 Thailand.
Cell Phone: +66 98016 6138 . Email_inquiry@medicalglove.net
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Image /page/6/Picture/0 description: The image shows the logo for MG Medical Glove. The letters "MG" are in large, bold, yellow font on the left side of the image. To the right of "MG" are the words "MEDICAL GLOVE" in a smaller, yellow font. The logo is simple and easy to read.
MEDICAL GLOVE CO., LTD
288 Moo 7 T. Lam Thap, A. Lam Thap, Krabi 81190 Thailand.
Cell Phone: +66 98016 6138 . Email_inquiry@medicalglove.net
| Characteristics | Standards | Device performance | ||
|---|---|---|---|---|
| Predicate | Current (K213934) | Comparison | ||
| Biocompatibility | Primary SkinIrritation -ISO 10993-10 ThirdEdition 2010-08-01 | Under the conditionsof the study, not anirritant | Under the conditionsof the study, not anirritant | Same |
| DermalSensitization -ISO 10993-10 ThirdEdition 2010-08-01 | Under the conditionsof the study, not asensitizer | Under the conditionsof the study, not asensitizer | Same | |
| In vitro cytotoxicityISO10993-5:2009(E) | No data is available | Under the conditions of thestudy, cytotoxic for undiluted,1:2, 1:4 and 1:8 dilutions, butnon-cytotoxic for 1:16 and1:32 dilutions. Moreover,under the conditions of thestudy, non acute systemictoxic. | Different | |
| Acute SystemicToxicity ISO10993-11:2017(E) | No data is available | Under the conditions of thestudy, did not induce anysystemic toxicity. | Different |
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standards.
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Image /page/7/Picture/0 description: The image shows the logo and contact information for Medical Glove Co., LTD. The logo features the letters "MG" in a stylized font, with the words "MEDICAL GLOVE" stacked vertically to the right of the letters. The contact information includes the company's address at 288 Moo 7 T. Lam Thap, A. Lam Thap, Krabi 81190 Thailand, as well as a cell phone number of +66 98016 6138 and an email address of inquiry@medicalglove.net.
7.0 Non-clinical testing summary
Performance Data
| Test Method | Standard | Purpose of testing | Acceptance Criteria | Result | Status |
|---|---|---|---|---|---|
| ASTM D6319-19Standard Specification for NitrileExamination Gloves for MedicalApplication | To determine the lengthof the gloves | Min 230 mm for all sizes | Extra Small: min 240 mmSmall: min 243 mmMedium: min 241 mmLarge: min 240 mmExtra Large: min 240 mm | Pass | |
| Dimension | ASTM D6319-19Standard Specification for NitrileExamination Gloves for MedicalApplication | To determine the widthof the gloves | Extra Small: $70 \pm 10$ mmSmall: $80 \pm 10$ mmMedium: $95 \pm 10$ mmLarge: $110 \pm 10$ mmExtra Large: $120 \pm 10$ mm | Extra Small: 75 mmSmall: 85 mmMedium: 95 mmLarge: 105 mmExtra Large: 115 mm | Pass |
| ASTM D6319-19Standard Specification for NitrileExamination Gloves for MedicalApplication | To determine thethickness of the gloves | Palm 0.05 mm minFinger 0.05 mm min for all sizes | Extra Small: Palm 0.09 mm, Finger: 0.12mmSmall: Palm 0.09 mm, Finger: 0.13 mmMedium: Palm: 0.09 mm, Finger: 0.12mmLarge: Palm 0.09 mm, Finger: 0.12 mmExtra Large: Palm 0.09 mm, Finger: 0.12mm | Pass | |
| Watertight test | ASTM D5151-19Standard Test Method for Detectionof Holes in MedicalGloves | To determine the holes inthe gloves | Sample size: 200 pcsInspection level : GIAQL 1.5Acceptance Number 7Rejection Number 8 | The batch size for this sampling is35,001-150,000. Hence, according to thesingle sampling plan GI, the sample to bedrawn is under code L equivalent to 200pcs with accept 7 and reject 8 to beaccept under AQL 1.5.Extra Small: 0 (Zero)Small: 0 (Zero)Medium: 0 (Zero)Large:0 (Zero)Extra Large:0 (Zero) | Pass |
| Test Method | Standard | Purpose of testing | Acceptance Criteria | Result | Status |
| Residualpowder | ASTM D6124-06 (Reapproved 2017)Standard Test Method for ResidualPowder on Medical Gloves | To determine the residualpowder in the gloves | 2 mg per glove or less | Sample size : 5 pcsRequirement: 2 mg per glove or lessResult:Extra Small: 1.35 mg/gloveSmall:1.42 mg/gloveMedium: 1.24 mg/gloveLarge: 1.34 mg/gloveExtra Large:1.36 mg/glove | Pass |
| PhysicalProperties | ASTM D6319-19Standard Specification for NitrileExamination Gloves for MedicalApplication | To Determine thephysical properties-Tensile strength | Before AgeingTensile Strength 14MpaMinimal for all sizesAfter Ageing TensileStrength 14MpaMinimal for all sizes | Before AgeingExtra Small: 18.08 MPaSmall: 18.37 MPaMedium: 24.56 MPaLarge: 18.30 MPaExtra Large: 18.20 MPaAfter ageing:Extra Small: 14.01 MPaSmall: 14.08 MPaMedium: 20.41 MPaLarge: 14.00 MPaExtra Large: 14.00 MPa | Pass |
| To Determine thephysical properties-Ultimate Elongation | Before AgeingUltimate Elongation500% Min for all sizesAfter Ageing UltimateElongation 400% Minfor all sizes | Before AgeingExtra Small: 611 %Small: 612%Medium: 645 %Large:620%Extra Large:587%After ageing:Extra Small: 412 %Small:408%Medium: 584%Large:403%Extra Large:416% | Pass |
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Image /page/8/Picture/0 description: The image shows the logo for MG Medical Glove. The letters "MG" are in large, bold, yellow font on the left side of the image. To the right of "MG" are the words "MEDICAL GLOVE" stacked on top of each other, also in yellow font. The logo appears to be for a medical glove company.
MEDICAL GLOVE CO., LTD
288 Moo 7 T. Lam Thap, A. Lam Thap, Krabi 81190 Thailand.
Cell Phone: +66 98016 6138 . Email: inquiry@medicalglove.net
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Image /page/9/Picture/0 description: The image shows the logo for MG Medical Glove. The letters "MG" are in large, bold, yellow font on the left side of the image. To the right of the letters "MG" is the text "MEDICAL GLOVE" in a smaller, yellow font.
MEDICAL GLOVE CO., LTD 288 Moo 7 T. Lam Thap, A. Lam Thap, Krabi 81190 Thailand.
Cell Phone: +66 98016 6138 . Email:inquiry@medicalglove.net
8.0 Clinical Testing Summary
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
9.0 Conclusion:
The conclusions drawn from the non-clinical test demonstrate that the subject device Nitrile Powder Free Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device K143131
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§ 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.