(94 days)
A 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.
Powder Free Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-10. 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 is a 510(k) Premarket Notification for Powder Free Nitrile Examination Gloves (K210369) by Pastel Glove Sdn Bhd. It compares the proposed device to a predicate device (K153562) to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Characteristic and Parameter | Acceptance Criteria (from predicate/ASTM) | Reported Device Performance (K210369) |
|---|---|---|
| Overall Length | Minimum 230mm | Average: 242 mm |
| Width (S) | 75mm - 95mm | Average: 84 mm |
| Width (M) | 85mm - 105mm | Average: 94 mm |
| Width (L) | 100mm - 120mm | Average: 103 mm |
| Palm Thickness | Minimum 0.05mm | Average: 0.06 mm |
| Finger Thickness | Minimum 0.05mm | Average: 0.08 mm |
| Tensile Strength (before age) | Minimum 14 MPa | Average: 17.75 MPa |
| Tensile Strength (after age) | Minimum 14 MPa | Average: 16.07 MPa |
| Ultimate Elongation (before age) | Minimum 500% | Average: 560% |
| Ultimate Elongation (after age) | Minimum 400% | Average: 510% |
| Freedom of Holes | Meet AQL 2.5 at G1 | Meet AQL 1.5 with G1 |
| Residual powder test | Less than 2mg/glove | S: 0.45 mg/glove, M: 0.43 mg/glove, L: 0.27 mg/glove |
| Primary Skin Irritation | Not an irritant (as per predicate) | Under the conditions of study, not an irritant |
| Dermal Sensitization | Not a sensitizer (as per predicate) | Under the conditions of study, not a sensitizer |
| Acute Systemic Toxicity | Not induce systemic toxicity (ISO 10993-11) | Not induce systemic toxicity |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the exact sample sizes used for each test. However, it references standards that imply specific sampling methodologies:
- ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection." This standard specifies sampling plans for lot-by-lot inspection based on Acceptable Quality Level (AQL). For "Freedom of Holes," the acceptance criterion is AQL 2.5 at G1, and the device met AQL 1.5 at G1, implying that the sampling was done in accordance with this standard.
- ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. This standard would also dictate sampling sizes and methods for physical property tests.
- ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06, Standard Test Method for Residual Powder on Medical Gloves.
- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity.
The data provenance is not explicitly stated in terms of country of origin but is likely generated by the manufacturer or a contracted lab to meet the specified standards. The tests appear to be prospective, performed specifically for this 510(k) submission to demonstrate compliance.
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 device is a medical glove, and the "ground truth" for its performance is established through objective physical, chemical, and biological testing according to established ASTM and ISO standards, not through expert consensus or interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are typical for subjective assessments, often in imaging or clinical scenarios where multiple experts might disagree on an interpretation. The tests for gloves (e.g., tensile strength, hole detection, chemical residue) are objective and measured against predefined criteria.
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 information is not applicable. An MRMC study is relevant for devices involving human interpretation, often aided by AI, especially in diagnostic imaging. This submission concerns a physical medical device (examination glove) and its inherent performance characteristics.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is a physical glove, not an algorithm or software. Therefore, there is no "algorithm only" performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance of these gloves is defined by:
- Established ASTM and ISO standards: These standards specify the acceptable ranges and methodologies for physical properties (e.g., thickness, tensile strength, elongation), barrier integrity (holes), and biocompatibility (skin irritation, sensitization, systemic toxicity).
- Objective measurements: The tests involve quantifiable measurements (e.g., mm for length/width/thickness, MPa for tensile strength, % for elongation, mg/glove for powder residue).
- Pass/fail criteria: Biocompatibility tests determine whether the device causes irritation, sensitization, or systemic toxicity under specific study conditions.
8. The sample size for the training set:
This information is not applicable. This is a physical medical device (examination glove), not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
This information is not applicable as there is no "training set" for this type of device submission.
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May 13, 2021
Pastel Glove Sdn Bhd Terence Lim RA Specialist PT285724, Jalan Pusing, Taman Perindustrian Perabot Negeri Park Pusing, Perak 31550, Malaysia
Re: K210369
Trade/Device Name: Powder Free Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 20, 2021 Received: April 26, 2021
Dear Terence Lim:
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,
For Ryan Ortega Acting 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) K210369
Device Name POWDER FREE NITRILE EXAMINATION GLOVE
Indications for Use (Describe)
A 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.
| 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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Pastel Glove Sdn Bhd
PT 285724, Jalan Pusing, Taman Perindustrial Perabot Negeri Perak, Pusing 31550, Perak, Malaysia
Attachment 2
510 (K) SUMMARY (K210369)
1.0 Submitter Pastel Glove Sdn Bhd PT 285724, Jalan Pusing, Taman Perindustrial Perabot Negeri Perak Pusin 31550, Perak, Malaysia
| Tel: | +60-19 552 5000 |
|---|---|
| Name of Contact Person: | Terence Lim |
| Email Address: | limsinkooi@@gmail.com |
| Date of Summary Prepared: | April 20, 2021 |
2.0 Name of Device:
| 510(k) number | K210369 |
|---|---|
| Trade Name: | Powder Free Nitrile Examination Glove |
| Classification Name: | Polymer Patient Examination Glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LZA |
3.0 Identification of The Legally Marketed Device
Predicate Device Name: Powder Free Blue Nitrile Examination Glove
Predicate 510(K) Number: K153562
Manufacturer's Name: VIETGLOVE CORPORATION
4.0 Description of Device
Powder Free Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-10. 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.
5.0 The Intended Use of Glove
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
6.0 Summary of the Technological Characteristic of the Device compared to the Predicate Device for Substantial Equivalent Discussion.
There is no difference in technology characteristic compared to the predicate device. Gloves are made from nitrile latex compound. Non-Sterile, Powder Free Nitrile Examination Gloves has the below technological characteristic compared to ASTM or Equivalent standards.
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Pastel Glove Sdn Bhd
PT 285724, Jalan Pusing, Taman Perindustrial Perabot Negeri Perak, Pusing 31550, Perak, Malaysia
Comparison between Proposed & Predicate Device
| Characteristics andParameters | Proposed Device -Powder Free NitrileExamination Gloves(K210369) | Predicate Device -Powder Free BlueNitrile ExaminationGloves (K153562 ) | Discussion |
|---|---|---|---|
| Product Code | LZA | LZA | Same product Code |
| Intended Use | A patient examinationglove is a disposabledevice intended formedical purposes thatis worn on the hand orfinger to preventcontamination betweenpatient and examiner. | A patient examinationglove is a disposabledevice intended formedical purposes thatis worn on the hand orfinger to preventcontaminationbetween patient andexaminer. | Same Intended Use. |
| Classification | Class 1 | Class 1: | Same Class. |
| Raw Rubber Material | Nitrile (Acrylonitrile-butadiene) | Nitrile (Acrylonitrile-butadiene) | Same synthetic rubbermaterial. |
| Surface Appearance | 1. Blue2. Ambidextrous3. Finger Textured | 1. Blue2. Ambidextrous3. Finger Textured | Same color, ambidextrousdesign and same texturearea. |
| Overall LengthMinimum 230mm | Average : 242 mm | 240 – 250 mm(specification sheet) | Similar |
| WidthS: 75mm - 95mmM: 85mm - 105mmL: 100mm - 120mm | Average :S : 84 mmM: 94mmL 103mm: | Meetingspecification | Similar |
| Palm Thickness(Minimum 0.05mm) | Average : 0.06 | More than 0.05mm | Similar |
| Finger Thickness(Minimum 0.05mm) | Average : 0.08 | More than 0.05mm | Similar |
| Tensile Strength(before age)Minimum 14 MPa | Average : 17.75 MPa | More than 14 MPa(Specification Sheet) | Similar |
| Tensile Strength(After Age)Minimum 14 MPa | Average : 16.07 MPa | More than 14 MPa(Specification Sheet) | Similar |
| Ultimate Elongationbefore age(Minimum 500%) | Average : 560% | 500% - 600%(Specification Sheet) | Similar |
| Ultimate Elongationafter age(Minimum 400%) | Average : 510% | 400% - 500%(Specification Sheet) | Similar |
| Characteristics andParameters | Proposed Device -Powder Free NitrileExamination Gloves(K210369) | Predicate Device -Powder Free BlueNitrile ExaminationGloves (K153562 ) | Discussion |
| Freedom of HolesMeet AQL 2.5 at G1 | Meet AQL 1.5 withG1 | Meet AQL 1.5 withG1. | Similar |
| Residual powder test(Less than2mg/glove) | Average powderresidue for each size:S : 0.45 mg/gloveM 0.43 mg/gloveL 0.27 mg/glove | Contained less than2mg/glove | Similar |
| Primary Skin Irritation | Under the conditionsof study, not anirritant | Under the conditionsof study, not anirritant | Similar |
| Dermal Sensitization | Under the conditionsof study, not asensitizer. | Under the conditionsof study, not asensitizer. | Similar |
| Acute SystemicToxicity | Not induce systemictoxicity | Not done | Meeting the requirementsper ISO 10993-11 |
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Pastel Glove Sdn Bhd
PT 285724, Jalan Pusing, Taman Perindustrial Perabot Negeri Perak, Pusing 31550, Perak, Malaysia
Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed
Device complies with the following standards:
- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And ● Skin Sensitization.
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic . toxicity
- ASTM D6124-06,Standard Test Method for Residual Powder on Medical Gloves ●
- ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves. ●
- . ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application
- ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes Part I: Sampling Plans ● Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
Clinical Test Conclusion
No clinical test is included in this submission
Conclusion
The conclusion drawn from the nonclinical tests demonstrates the subject device in 510(K) submission K210369. Powder Free Nitrile Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153562.
§ 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.