(53 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 Patient Examination Glove, Non-Sterile (Blue) meet all the requirements of ASTM standard D6319-19 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.
The provided document is a 510(k) premarket notification for Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue). This is a medical device of Class I and the submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI/ML algorithm.
Therefore, the requested information about AI model acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets is not applicable to this document.
The document describes the acceptance criteria and device performance as they relate to the physical and biocompatibility characteristics of the examination gloves. Here's a summary based on the provided text:
1. Acceptance Criteria and Reported Device Performance for Powder Free Nitrile Patient Examination Gloves
The acceptance criteria for these medical gloves are primarily based on established ASTM (American Society for Testing and Materials) and ISO standards. The reported device performance is compared against these standards and the predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard/Test Method | Acceptance Criteria | Device Performance (Current Blue) | Status | Compared to Predicate |
|---|---|---|---|---|---|
| Material | ASTM D6319-10 | Nitrile | Nitrile | Same | Same |
| Color | - | Blue | Blue | Same | Same |
| Texture | - | Finger textured | Finger textured | Same | Same |
| Physical Properties | |||||
| Before Aging | ASTM D6319-10 (Tensile Test: ASTM D412-16) | Tensile Strength: ≥ 14MPa; Ultimate Elongation: ≥ 500% | Tensile Strength: 15.3 MPa (Pass); Ultimate Elongation: 500% (Pass) | Pass | Same |
| After Aging | ASTM D6319-10 (Tensile Test: ASTM D412-16) | Tensile Strength: ≥ 14MPa; Ultimate Elongation: ≥ 400% | Tensile Strength: 14.8 MPa (Pass); Ultimate Elongation: 460% (Pass) | Pass | Same |
| Thickness | ASTM D6319-19 (Measurement: ASTM D3767-03) | Finger: 0.07-0.10mm; Palm: 0.06-0.09mm; Cuff: 0.06-0.08mm | Finger: 0.07-0.10mm; Palm: 0.06-0.09mm; Cuff: 0.06-0.08mm (Within ranges) | Pass | Similar |
| Powder Free | ASTM D6124-06 | ≤ 2 mg/glove | 1.5 mg/glove | Pass | Same |
| Biocompatibility | |||||
| Primary Skin Irritation | ISO 10993-10:2010 | Passes (Not a primary skin irritant); PII = 0 | Passes (Not a primary skin irritant); PII = 0 | Pass | Similar |
| Dermal Sensitization | ISO 10993-10:2010 | Passes (Not a contact sensitizer); No allergic reaction observed | Passes (Not a contact sensitizer); No allergic reaction observed | Pass | Similar |
| Cytotoxicity | ISO 10993-5:2009 (MEM Elution) | No cytotoxicity reactivity at specific extract concentrations (e.g., 12.5%, 6.25%, 3.125%) | No cytotoxicity reactivity at 12.5%, 6.25%, 3.125% extract concentrations | Pass | Similar |
| Acute Systemic Toxicity | ISO 10993-11:2017 (E) | Passes (no adverse biological reaction); No mortality observed | Passes (no adverse biological reaction); No mortality observed | Pass | Not Available for Predicate |
| Watertight (Hole Detection) | ASTM D5151-19 | Inspection Level 1, AQL 1.5; Acceptance No: 10 (for a sample size of 315) | 6 pieces found with leaks (within acceptance criteria) | Pass | Same |
| Dimension | ASTM D3767-03 (2020) | Length: Min 240mm; Width (XS: 70±10mm, S: 80±10mm, M: 95±10mm, L: 110±10mm, XL: >110mm); Thickness: Finger ≥ 0.05mm, Palm ≥ 0.05mm | Length: Min 240mm (Pass); Width (Ave: 72mm-113mm for sizes, all Pass); Thickness: Finger 0.10mm, Palm 0.06mm (Pass) | Pass | Part of "Similar" Thickness |
2. Sample Sizes Used for Testing and Data Provenance
The sample sizes for testing are defined by the specific ASTM standards followed.
- Physical Properties (Tensile Strength, Elongation): Not explicitly stated, but typically these tests involve a specified number of specimens per batch or test run according to ASTM D412.
- Watertight (Hole Detection): Sample size of 315 pieces for a batch sampling of 150,001 to 500,000 gloves, based on Inspection Level GI and AQL 1.5. This is a prospective test conducted on manufactured gloves.
- Powder Free (Residual Powder): Sample size of 5 pieces.
- Biocompatibility Tests (Skin Irritation, Sensitization, Cytotoxicity, Systemic Toxicity): These tests are typically conducted on animal models (e.g., mice, rabbits) and cell cultures. The counts of animals (e.g., number of test group animals vs. control group animals) are not explicitly stated in this summary, but the results (e.g., "no mortality," "no erythema") indicate biological testing. This data would be prospective from laboratory testing.
- Data Provenance: The manufacturing company is Meditech Gloves Sdn Bhd, Malaysia. The tests described are laboratory and quality control tests conducted as part of the manufacturing and regulatory submission process.
3. Number of Experts and Qualifications for Ground Truth
This type of medical device submission (examination gloves) does not involve human expert interpretation of images or complex diagnostic data like an AI/ML device would. Therefore, there are no "experts establishing ground truth" in the diagnostic sense. The "ground truth" for the performance of these gloves is defined by the objective, quantifiable results of the standardized physical and biocompatibility tests (e.g., direct measurements of tensile strength, elongation, amount of powder, number of leaks, observed biological reactions in laboratory tests).
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The tests are objective and quantitative.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML diagnostic device that interacts with human readers or interprets medical cases.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is a physical examination glove, not an algorithm.
7. Type of Ground Truth Used
The ground truth used for this device is based on objective, quantitative measurements and laboratory test results against established international standards (ASTM, ISO) for material properties, physical dimensions, leak detection, and biocompatibility.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply here.
In summary, the provided document is a regulatory submission for a physical medical device (examination gloves) where "acceptance criteria" relate to meeting specific physical and biological performance standards, not to the performance of an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
May 7, 2021
Meditech Gloves SDN BHD Wan Hassan Assistant Manager - QA/RA PT 3345, Jalan Permata 1/3, Arab Malaysian Industrial Park Nilai, Negeri Sembilan 71800 Malaysia
Re: K210755
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: March 5, 2021 Received: March 15, 2021
Dear Wan Hassan:
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, Ph D. 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) K210755
Device Name
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
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) |
|---|
| ------------------------------------------------- |
| Residential (Dwelling) CER-WA Category 1 |
|---|
| Care-Type Community Health CER-WA Category 2 |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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1.0 Submitter:
| Name: | Dr Effendi Tenang |
|---|---|
| Address: | Meditech Gloves Sdn BhdPT3345, Jalan Permata 1/3, Arab Malaysian Industrial Park,71800 Nilai, Negeri Sembilan, MALAYSIA |
| Phone No.: | +60 6 799 7742 |
| Fax No.: | +60 6 799 7749 |
Date of Summary Prepared: May 4, 2021
2.0 Name of the device:
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Common Name: Examination Gloves Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LZA)
3.0 Identification of The Legally Marketed Devices that equivalency is claimed:
Dermagrip Powder Free Blue Nitrile Examination Gloves 510(k): K133168 Regulatory Class I Product Code: LZA
4.0 Description of The Device:
Powder Free Nitrile Patient Examination Glove, Non-Sterile (Blue) meet all the requirements of ASTM standard D6319-19 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from synthetic rubber Inner surface of gloves undergoes surface treatment process to produce a latex. smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.
5.0 Intended Use of the Device:
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.
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6.0 Comparison of the Technological Characteristics of the Device:
The Powder Free Nitrile Examination Gloves, Non-Sterile (Blue) are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
|---|---|---|---|---|
| PREDICATEBLUE | CURRRENTBLUE | |||
| 510(k) Number | - | K133168 | K210755 | N/A |
| Manufacturer(s) | - | WRP Asia Pacific Sdn Bhd | Meditech Gloves Sdn Bhd | Same |
| Material | ASTM D6319-10 | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger textured | Finger textured | Same |
| Physical Properties | ASTM D6319-10 | |||
| Before AgingTensile Strength :Ultimate Elongation : | 14MPa min500% min | 14MPa min500% min | Same | |
| After AgingTensile Strength :Ultimate Elongation : | 14MPa min400% min | 14MPa min400% min | Same | |
| Thickness - Finger- Palm- Cuff | ASTM D6319-19 | 0.07-0.10mm0.07-0.09mm0.06-0.08mm | 0.07- 0.10mm0.06- 0.09mm0.06- 0.08mm | Similar |
| Powder Free | ASTM D6124-06 | ≤ 2 mg/glove | ≤ 2 mg/glove | Same |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISONANALYSIS | |
| PREDICATEBLUE | CURRRENTBLUE | |||
| Biocompatibility | Primary Skin Irritation -ISO 10993-10:2010 | Passes (Not a primary skinirritant)There was no erythema oroedema noted on test site after(24±2), (48±2) and (72±2)hours. The primary IrritationIndex (PII) was "0" | Passes (Not a primary skinirritant)There was no erythema oroedema noted on test site after(1±0.1), (24±2), (48±2) and(72±2) hours. The primaryIrritation Index (PII) was "0".Also, no mortality after 72hours. The gloves considerednegligible. | Similar |
| Biocompatibility | Dermal Sensitization- ISO10993-10:2010 | Passes (Not a contactsensitizer)There was no positive allergicreaction observed during thechallenge phase (at 24 hoursand 48 hours) in animalstreated with the test materialand negative control. | Passes (Not a contactsensitizer)There was no positive allergicreaction observed during thechallenge phase (at 0, 24hours and 48 hours) inanimals treated with the testmaterial and negative control. | Similar |
| Biocompatibility | Cytotoxicity - MEM Elution,ISO 10993-5:2009 | Exhibit severe cytotoxicityreactivity at 100%, 66%, 44%and 30% extract concentration.Slight cytotoxicity reactivity at20% and no cytotoxicityreactivity at 15% extractconcentrations. | Exhibit severe cytotoxicityreactivity at 100%, 50%, and25% extract concentration.No cytotoxicity reactivity at12.5%,6.25% and 3.125%extract concentrations. | Similar |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
| PREDICATE | CURRENT | |||
| BLUE | BLUE | |||
| Biocompatibility | Acute Systemic Toxicity,ISO 10993-11:2017 (E) | Not Available | Passes (no adverse biologicalreaction)No mortality was observed(72±2) hours | Not Available |
| Watertight (1000ml) | ASTM D5151-19 | InspectionLevel 1, AQL 1.5 | InspectionLevel 1, AQL 1.5 | Same |
| Intended use | A patient examination glove isa disposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination between patientand examiner. | A patient examination gloveis a disposable deviceintended for medical purposesthat is worn on theexaminer's hand or finger toprevent contaminationbetween patient andexaminer. | Same | |
| Size | Medical Glove GuidanceManual - Labeling | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large | Same |
| Single Use | Medical Glove GuidanceManual – Labeling | Single use | Single use | Same |
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There are no significant differences between the two products and they are the same or similar in terms of intended use, materials, design, manufacturing methods.
7.0 Summary of Non-Clinical Performance Data
The performance test data of the non-clinical tests for this powder free nitrile examination gloves is summarized as per below.
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| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | ||
|---|---|---|---|---|---|---|---|
| PhysicalProperties | ASTM D412-16(Standard Test Methodfor Vulcanized Rubberand ThermoplasticElastomers-Tension) | To evaluate the tensile(tension) properties ofglove. | TensileStrength | Min 14MPa | 15.3 | 14.8 | Pass |
| UltimateElongation | Min 500% | 500 | 460 | Pass | |||
| Min 400% |
| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | |
|---|---|---|---|---|---|---|
| Dimension | ASTM D3767-03(2020) StandardPractice for Rubber –Measurement ofDimensions | To measure thelength, width, andthickness of glove | Length | Min 240mm | Min 240 | Pass |
| Width: | ||||||
| XS | 70 ± 10 mm | Ave = 72 mm | Pass | |||
| S | 80 ± 10 mm | Ave = 84 mm | Pass | |||
| M | 95± 10 mm | Ave = 95 mm | Pass | |||
| L | 110 ± 10 mm | Ave = 102 mm | Pass | |||
| XL | >110 | Ave = 113 mm | Pass | |||
| Thickness | Finger – 0.05mmPalm – 0.05mm | Thickness Finger – 0.10mmPalm – 0.06mm | Pass |
| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| ---------------- | ---------- | -------------------- | --------------------- | --------- | -------- |
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| Water Tight | ASTM D 5151-19Standard Test Methodfor Detection of Holesin Medical Gloves | To detect holes thatleak water and therebycompromise theusefulness of the glove | Sample Size : 315Inspection Level : GIAQL : 1.5Acceptance No : 10 | This batch sampling is 150,001 to500,000. Hence according to singlesampling plan GI, the sample to bedrawn is under Code M equivalentto 315 pieces with accept 10 andreject 11.During the test , 6 pieces werefound with leaks. Hence it fallswithin the acceptance criteria. | Pass |
|---|---|---|---|---|---|
| ------------- | --------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------ |
| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| ResidualPowder | ASTM D6124-06(2017) Standard TestMethod for ResidualPowder on MedicalGloves | To determine theamount of residualpowder and non-powder solids found ongloves | Less than 2 mg per glove | Sample size : 5 pcsRequirement : <2mg/gloveResult : 1.5 mg/glove | Pass |
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8.0 Summary of Clinical Performance Data
Not applicable - Clinical data was not used to assess performance of the subject device.
9.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) (K210775), is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Dermagrip Powder Free Blue Nitrile Examination Gloves (K133168).
§ 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.