(157 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Powder Free Blue Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
The document provided describes the acceptance criteria and performance data for a Powder Free Nitrile Examination Glove (Blue), K220284, in comparison to a predicate device. This is a medical device submission, and the studies described are non-clinical performance data to demonstrate substantial equivalence, not studies related to AI or diagnostic algorithms. Therefore, many of the requested fields related to AI/algorithm performance (e.g., MRMC studies, standalone performance, training set details) are not applicable.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D6319-19: Dimensions | To measure the physical length and width of the gloves | Length: XS-Min 220mm, S-Min 220mm, M-Min 230mm, L-Min 230mm, XL-Min 230mm | Minimal Value for Length: XS: 240mm, S: 246mm, M: 240mm, L: 250mm, XL: 251mm | PASS |
| Width: XS-70 ± 10mm, S-80 ± 10mm, M-95 ± 10mm, L-110 ± 10mm, XL-120 ± 10mm | Minimal Value for Width: XS: 73mm, S: 84mm, M: 93mm, L: 104mm, XL: 111mm | PASS | ||
| ASTM D6319-19: Physical Properties | To measure the tensile strength and elongation before and after aging | Tensile Strength: Before Aging: 14.0 MPa, After Aging: 14.0 MPa | Tensile Strength: Before Aging: Minimal Value: 19.10 MPa, After Accelerated Aging: Minimal Value: 19.0 MPa | PASS |
| Ultimate Elongation: Before Aging: min. 500%, After Aging: min. 400% | Ultimate Elongation: Before Aging Minimal Value: 520%, After Aging Minimal Value: 480% | PASS | ||
| ASTM D6319-19: Thickness | To measure the physical palm and finger thickness of the gloves | Palm-Min. 0.05mm | Palm Minimal Value: XS: 0.07mm, S: 0.07mm, M: 0.07mm, L: 0.07mm, XL: 0.07mm | PASS |
| Finger-Min. 0.05mm | Finger Minimal Value: XS: 0.11mm, S: 0.11mm, M: 0.11mm, L: 0.11mm, XL: 0.12mm | PASS | ||
| ASTM D6319-19: Freedom from Holes Testing | To detect the presence of holes in glove | Meet AQL 2.5 at G1 | Meet AQL 2.5 at G1 | PASS |
| ISO 10993-10: Primary Skin Irritation | To determine the irritation potential of glove when exposed to skin surface | Not an irritant | Under the condition of study, not an irritant | PASS |
| ISO 10993-10: Dermal Sensitization | To determine the sensitization potential of glove when exposed to skin surface | Not a Sensitizer | Under the condition of study, not a sensitizer | PASS |
| ISO 10993-11: Acute Systemic Toxicity | To evaluate the adverse systemic reaction potential from glove | Not induce systemic toxicity | Did not induce systemic Toxicity | PASS |
| ASTM D6124-06: Residual Powder Analysis | To check the amount of powder residue from glove surface | Residual powder test (< 2 mg/glove) | Average 0.10mg/glove | PASS |
2. Sample size used for the test set and the data provenance
The document specifies "Minimal Value" and "Average" for various measurements, indicating that multiple samples were tested, but it does not provide the exact sample size for each test (e.g., number of gloves tested for dimensions, physical properties, etc.).
Data provenance: The testing was performed by KGM Gloves Sdn. Bhd. for their own device. The location of the manufacturer is Malaysia. The testing data is non-clinical performance data, likely gathered prospectively as part of product development and quality control.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" here refers to objective physical and chemical properties measured by standardized tests (e.g., ASTM and ISO standards) and laboratory procedures, not expert interpretation of medical images or other subjective assessments.
4. Adjudication method for the test set
Not applicable. The tests involve objective measurements and standardized protocols, not human adjudication.
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 document is for a physical medical device (examination gloves), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used
The ground truth used consists of objective measurements and laboratory test results against established international and national standards (ASTM D6319-19, ISO 10993-10, ISO 10993-11, ASTM D6124-06). For example, a glove's length is its measured length, and its tensile strength is the result obtained from the specified test method.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning/AI device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" as this is not a machine learning/AI device.
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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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 8, 2022
KGM Gloves Sdn. Bhd. Ooi Seng RA Manager Lot 18893 & 18894, Jalan Perusahaan 9, Kawasan Perusahaan Kamunting. Perak 34600 Malaysia
Re: K220284
Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: May 10, 2022 Received: May 16, 2022
Dear Ooi Seng:
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
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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 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,
Clarence W. Murray, III, PhD 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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Indications for Use
510(k) Number (if known) K220284
Device Name Powder Free Nitrile Examination Gloves (Blue)
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers 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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1.0 510 (K) SUMMARY 510(k) Number: K220284
2.0 Submitter:
KGM Gloves Sdn. Bhd. Lot 18893 & 18894, Jalan Perusahaan 9, Kawasan Perusahaan Kamunting, 34600 Kamunting, Perak, Malaysia. Tel: +605-891 3612 Fax: +605-891 6612
Establishment Registration Number: 3020763216
Contact Person:
Ooi Loon Seng (Mdm) i) (ii) Contact No: +6012-4612918 Email: loonsenq54@gmail.com
Melissa Oon Contact No: +6012-4730656 Email: melissaoon@gmail.com
Date of Preparation : January 15, 2022
3.0 Name of the Device
Trade Name: Powder Free Nitrile Examination Glove (Blue) Classification Name: Patient Examination Glove Device Classification: Class I Regulation Number: 21 CFR 880.6250 Product Code: LZA
4.0 Identification of The Legally Marketed Predicate Device
Predicate Device Name: Powder Free Blue Nitrile Examination Glove Predicate 510(K) Number: K210375 Manufacturer's Name: Duramitt Sdn. Bhd. Device Classification: Class I Regulation Number: 21 CFR 880.6250 Product Code: LZA
5.0 Description of Device
Powder Free Blue Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
6.0 The Intended Use of Device
The Powder Free Nitrile Examination Glove (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
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7.0 Summary of the Technological Characteristic Comparison of the Device
Provided below is a comparison of the subject device and the predicate device
| Characteristics andParameters | Proposed Device -Powder Free NitrileExamination Gloves | Predicate Device -Powder Free BlueNitrile ExaminationGloves (K210375) | Comparison |
|---|---|---|---|
| Product Code | LZA | LZA | Identical |
| Intended Use | A patient examinationglove is a disposabledevice intended formedical purposes that isworn on the examiner'shands or fingers toprevent contaminationbetween patient andexaminer. | A patient examinationglove is a disposabledevice intended formedical purposes that isworn on the hand orfinger to preventcontamination betweenpatient and examiner. | Identical |
| Device Classification | Class I | Class I | Identical |
| Device material | Nitrile(Acrylonitrile butadiene) | Nitrile(Acrylonitrile butadiene) | Similar |
| Colour | Blue | Blue | Similar |
| Instruction forUse on Labeling | Single Use only. | Single Use only. | Identical |
| Construction | Ambidextrous | Ambidextrous | Identical |
| Freedom from holes | Meet AQL 2.5 at G1 | Meet AQL 1.5 at G1 | Same |
| Length:XS-Minimum 220mmS-Minimum 220mmM-Minimum 230mmL-Minimum 230mmXL-Minimum 230mm | Minimal Value for Length:XS: 240mmS: 246mmM: 240mmL : 250mmXL: 251mm | AverageXS:-S: 242mmM: 242mmL : 243mmXL:- | Similar |
| Width:-XS-70 ± 10mmS-80 ± 10mmM-95 ± 10mmL-110 ± 10mmXL-120 ± 10mm | Minimal Value for Width:XS: 73mmS: 84 mmM: 93 mmL: 104 mmXL: 111mm | AverageXS:-S: 84mmM: 96mmL : 107mmXL:- | Similar |
| Palm ThicknessMinimum 0.05mm | Palm Minimal Value:XS: 0.07mmS: 0.07mmM: 0.07mm | AverageXS:-S: 0.06mmM: 0.06mm | Similar |
| L : 0.07mm | L : 0.06mm | ||
| XL: 0.07mm | XL:- | ||
| Finger ThicknessMinimum 0.05mm | Finger Minimal Value:XS: 0.11mmS: 0.11mmM: 0.11mmL : 0.11mmXL: 0.12mm | AverageXS:-S: 0.08mmM: 0.08mmL : 0.08mmXL:- | Similar |
| Tensile Strength(Before age)Minimum 14.0MPa | Minimum 19.1MPa | Average 19.04MPa | Similar |
| Tensile Strength(After Age)Minimum 14.0MPa | Minimum 19.0MPa | Minimum 14.0MPa | Different |
| Ultimate Elongation(Before age)Minimum 500% | Minimum 520% | Average 560% | Similar |
| Ultimate Elongation(After age)Minimum 400% | Minimum 480% | Average 510% | Similar |
| Residual powder test(<2mg/glove) | Average 0.10mg/glove | Average 0.59mg/glove | Similar |
| Primary Skin Irritation | Under the condition ofstudy, not an irritant | Under the condition ofstudy, not an irritant | Same |
| Dermal Sensitization | Under the condition ofstudy, not a sensitizer | Under the condition ofstudy, not a sensitizer | Same |
| Acute SystemicToxicity | Not induce systemictoxicity | Not induce systemictoxicity | Same |
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Summary of Non-Clinical Performance Data 8.0
Provided in the table below is the summary of the non-clinical testing performed with the subject device. The results demonstrate that the subject device met the acceptance criteria.
| Test Methodology | Purpose | Acceptance Criteria | Results | Width:XS-70 ± 10mmS-80 ± 10mmM-95 ± 10mmL-110 ± 10mmXL-120 ± 10mm | Minimal Value for Width:XS: 73mmS: 84 mmM: 93 mmL: 104 mmXL: 111mmPASS | ||
|---|---|---|---|---|---|---|---|
| ASTM D6319-19:Dimensions | To measure thephysical length andwidth of the gloves | Length:XS-Minimum 220mmS-Minimum 220mmM-Minimum 230mmL-Minimum 230mmXL-Minimum 230mm | Minimal Value forLength:XS: 240mmS: 246mmM: 240mmL : 250mmXL: 251mm | ASTM D6319-19:PhysicalProperties | To measure the tensile strength and elongation before and after aging | Tensile Strength: Before Aging: 14.0 MPa After Aging: 14.0 MPa | Tensile Strength: Before Aging: Minimal Value: 19.10 MPa After Accelerated Aging: Minimal Value: 19.0 MPa |
| Ultimate Elongation:Before Aging: min. 500%After Aging: min. 400% | Ultimate Elongation: Before Aging Minimal Value: 520% After Aging Minimal Value: 480%PASS | ||||||
| ASTM D6319-19:Thickness | To measure the physical palm and finger thickness of the gloves | Palm-Min. 0.05mm | Palm Minimal Value:XS: 0.07mmS: 0.07mmM: 0.07mmL : 0.07mmXL: 0.07mm | ||||
| Finger-Min. 0.05mm | Finger Minimal Value:XS: 0.11mmS: 0.11mmM: 0.11mmL : 0.11mmXL: 0.12mmPASS |
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| ASTM D6319-19:Freedom fromHolesTesting | To detect thepresence of holein glove | Meet AQL 2.5 at G1 | Meet AQL 2.5 at G1PASS |
|---|---|---|---|
| ISO 10993-10:Primary SkinIrritation | Todeterminetheirritation potential ofglove when expose toskin surface. | Not an irritant | Under the condition ofstudy, not an irritantPASS |
| ISO 10993-10:DermalSensitization | Todeterminethesensitizationpotential of glovewhen expose to skinsurface | Not a Sensitizer | Under the condition ofstudy, not a sensitizerPASS |
| ISO 10993-11:Acute SystemicToxicity | Toevaluatetheadversesystemicreactionpotentialfrom glove | Not induce systemic toxicity | Did not induce systemicToxicityPASS |
| ASTM D6124-06:Residual PowderAnalysis | To check the amountof powder residuefrom glove surface | Residual powder test( $<2$ mg/glove) | Average 0.10mg/glovePASS |
Summary of Clinical Performance Data 9.0
Not applicable - Clinical data is not needed for the subject device, gloves.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K210375.
§ 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.