(88 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.
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile meet all requirements of ASTM standard D6319 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.
This document is a 510(k) premarket notification for a disposable patient examination glove. This type of device does not typically involve AI components or complex clinical studies for its clearance. Therefore, a significant portion of the requested information, particularly regarding AI development, ground truth establishment, expert consensus, and MRMC studies, is not applicable to this document.
Here's the information that can be extracted from the provided text, aligning with the categories requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| CHARACTERISTICS | STANDARDS | Acceptance Criteria (from Standards) | Device Performance | Comparison Analysis |
|---|---|---|---|---|
| Physical Properties | ||||
| Before Aging | ASTM D6319, | Tensile Strength: Min 14.0 MPa | Tensile Strength: 32.35 MPa | Different but within the ASTM standard |
| Tensile Strength | ASTM D412 | Ultimate Elongation: Min 500% | Ultimate Elongation: 568% | Different but within the ASTM standard |
| After Aging | ASTM D6319, | Tensile Strength: Min 14.0 MPa | Tensile Strength: 36.10 MPa | Different but within the ASTM standard |
| Tensile Strength | ASTM D412 | Ultimate Elongation: Min 400% | Ultimate Elongation: 551% | Different but within the ASTM standard |
| Thickness | ASTM D6319, | Finger: min 0.05mm | Finger: 0.10 mm | Different but within the ASTM standard |
| ASTM D3767 | Palm: min 0.05mm | Palm: 0.07 mm | Different but within the ASTM standard | |
| Powder Free | ASTM D6124 | Less than 2 mg per glove | 0.24 mg/glove | Different but within the ASTM standard |
| Biocompatibility | ||||
| Primary Skin Irritation | ISO 10993-10:2010 | Not an irritant | 'Negligible' irritant response | Similar (both found not an irritant) |
| Dermal Sensitization | ISO 10993-10:2010 | Not a sensitizer | No skin sensitization effect | Similar (both found not a sensitizer) |
| Cytotoxicity | ISO 10993-5:2009 | Not cytotoxic (initial) | Cytotoxic effect (further tested) | Similar (both initially cytotoxic, clarified by AT) |
| Acute Systemic Toxicity | ISO 10993-11:2017 | No systemic toxicity concern | No systemic toxicity | Similar (both found no systemic toxicity concern) |
| Watertight | ASTM D5151:2019 | AQL 1.5, Acceptance No. 10 (for 315 pcs sample size) | 1 piece found with leaks (within AQL 1.5) | Same (both passed AQL 1.5) |
| Dimensions | ASTM D3767 | Length: Min 240 mm | Length: 248-250 mm | Pass |
| (for all sizes) | Width: e.g., 70 +/- 10 mm (X-Small) | Width: e.g., 78.0 mm (X-Small) | Pass |
Note: For characteristics like dimensions and biocompatibility, the provided text often states "Similar" or "Same" without explicitly detailing identical acceptance criteria across both tables presented, but it's implied that the new device meets the same underlying standards as the predicate.
2. Sample size used for the test set and the data provenance:
-
Physical Properties: The sample size for physical properties testing (tensile strength, elongation) is not explicitly stated numerically, but the tests were performed "Before Aging" and "After Aging" according to ASTM D412.
-
Watertight Test:
- Sample Size: 315 pieces (referencing a single sampling plan G1 for a batch size of 150,001 to 500,000, with AQL 1.5).
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Residual Powder:
- Sample Size: 5 pieces
-
Biocompatibility Tests: Sample sizes for these tests (e.g., number of animals for irritation/sensitization, cells for cytotoxicity) are not specified in this document but are part of the respective ISO standards.
-
Data Provenance: The testing was conducted by Onetexx Sdn Bhd, a manufacturer based in Kamunting, Perak, Darul Ridzuan, Malaysia. The data is prospective, generated specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a medical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM and ISO), not through expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The evaluation relies on standardized test methods with objective measurements, not subjective interpretation requiring 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 device is a medical glove, it does not involve AI or human "readers" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not have an algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is defined by the objective thresholds and methodologies specified in internationally recognized standards (ASTM D6319, ASTM D412, ASTM D3767, ASTM D6124, ASTM D5151, ISO 10993 series). These standards outline accepted levels of performance for physical properties, dimensions, watertightness, residual powder, and biocompatibility.
8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable. This device does not involve a training set.
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May 7, 2021
Onetexx SDN BHD % Michael Woude U.S. Agent Emergo Global Representation 2500 Bee Cave Road. Building 1 Suite 300 Austin, Texas 78746
Re: K210366
Trade/Device Name: Blue Nitrile Powder Free Patient Examination Glove, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: February 3, 2021 Received: February 8, 2021
Dear Michael Woude:
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
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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 (OS) 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,
For Ryan Ortega, Ph. D Acting Assistant Director DHT4A: Division of General 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) K210366
Device Name BLUE NITRILE POWDER FREE PATIENT EXAMINATION GLOVE, NON STERILE
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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510(k) No: K210366
1.0 Submitter:
| Name: | Freddy Low |
|---|---|
| Address: | Onetexx Sdn BhdNo: 73-86, Jalan Logam 5, Perindustrian Kamunting 3,Kamunting Raya Industrial Estate, 34600 Kamunting, PerakDarul Ridzuan, Malaysia |
| Phone No.: | +60 5 8070 666 |
| Fax No.: | +60 5 8070 666 |
Date of Summary Prepared: 3rd February 2021
2.0 Identification of the subject device:
: Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile Trade Name Common Name : Patient Examination Gloves Classification Name : Patient Examination Gloves Device Classification : 1 Regulation Number : 21 CFR 880.6250 Product Code : LZA.
3.0 Predicate Device:
K192333
Blue Nitrile Examination Gloves Powder Free Company: JR Engineering & Medical Technologies (M) SDN. BHD.
4.0 Description of The Device:
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250.
The powder free nitrile examination qlove 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.
5.0 Indication for use:
A patient examination glove is a disposable device made of synthetic rubber latex 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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510(k) No: K210366
Summary of the Technological Characteristics of the Device: 6.0
The Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1.
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510(k) No: K210366
Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISONANALYSIS | |
|---|---|---|---|---|
| PREDICATEBLUE | CURRENTBLUE | |||
| 510(k) Number | - | K192333 | ||
| Manufacturer(s) | - | JR Engineering & MedicalTechnologies (M) SDN. BHD. | Onetexx Sdn Bhd | Same |
| Material | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger texture | Finger Texture | Same |
| Physical PropertiesBefore AgingTensile Strength:Ultimate Elongation: | ASTM D6319 | 25.6Mpa868% | 32.35Mpa568% | Different butwithin the ASTMstandard |
| After AgingTensile Strength:Ultimate Elongation: | ASTM D6319 | 22.0Mpa828% | 36.10Mpa551% | Different butwithin the ASTMstandard |
| Thickness:- Finger- Palm | ASTM D6319 | 0.22mm0.20mm | 0.10mm0.07mm | Different butwithin the ASTMstandard |
| Powder Free | ASTM D6124 | 0.21 mg/glove | 0.24 mg/glove | Different butwithin the ASTMstandard |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
| PREDICATEBLUE | CURRENTBLUE | |||
| Biocompatibility | Primary Skin Irritation- ISO 10993-10:2010(E) & ConsumerProduct SafetyCommission Title 16.Chapter II, Part 1500 | Under the condition of study not an irritant | The test material did not cause an irritant response. The Primary Irritant Response Category is deemed 'Negligible' | Similar |
| Dermal Sensitization-ISO 10993-10: 2010(E) & ConsumerProduct SafetyCommission, Title 16,Chapter II, Part1500.3 (c) (4) | Under the conditions of the study not a sensitizer | The test material did not produce a skin sensitization effect in the guinea pigs. | Similar | |
| Cytotoxicity - MEMElution, ISO 10993-5:2009 (E) | Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern. | The test material demonstrated a cytotoxic effect under the condition of this study. Additional test i.e. Acute Systemic Toxicity was tested. | Similar |
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| DEVICE PERFORMANCE | ||||
|---|---|---|---|---|
| CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISONANALYSIS |
| BLUE | BLUE | |||
| Biocompatibility | Acute SystemicToxicity, ISO 10993-11:2017 (E) | Under the conditions of study,the device extracts do not posea systemic toxicity concern | The test item did not induceany systemic toxicity. | Similar |
| Watertight (1000ml) | ASTM D5151:2019 | Gloves passes AQL 1.5 | Gloves passed AQL 1.5 | Same |
| Intended use | JR MEDIC Blue NitrileExamination Gloves PowderFree is disposable devicesintended for medical purposethat are worn on the examiner'shand to prevent contaminationbetween patient and examiner. | A patient examination glove is adisposable device made ofsynthetic rubber latex intendedfor medical purposes that isworn on the examiner's hand orfinger to prevent contaminationbetween patient and examiner. | Same | |
| Size | Medical GloveGuidance Manual –Labeling | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large | Same |
| Single use | Medical GloveGuidance Manual –Labeling | Single Use | Single Use | Same |
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510(k) No: K210366
There are no significant differences between the two products and are identical in terms of intended use, materials design and biocompatibility test, however the performance data for proposed product is different on the physical properties (higher on Tensile Strength but lower on the elongation compared to predicate device) and glove thickness (lower than the predicate device) but well within the ASTM D 6139 standard.
7.0 Summary of Non-Clinical Testing
The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below.
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| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | |||
|---|---|---|---|---|---|---|---|---|
| Beforeaging | Afteraging | Beforeaging | Afteraging | |||||
| PhysicalProperties | ASTM D412(Standard TestMethod forVulcanized Rubberand ThermoplasticElastomers-Tension) | To evaluate thetensile (tension)properties of glove. | Tensilestrength | Min 14.0MPa | Min 14.0MPa | 32.35Mpa | 36.10Mpa | Pass |
| Ultimateelongation | Min500% | Min400% | 568% | 551% | Pass |
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| TestMethod | Standard | Purpose ofTesting | GloveSize | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|---|
| Dimension | ASTM D3767StandardPractice forRubber—Measurementof Dimensions | To measure thelength, width andthickness ofglove | X-Small | LengthMin 240 mmWidth$70 \pm 10$ mmThicknessFinger – min 0.05mmPalm - min 0.05mm | Length250 mmWidth78.0 mmThickness0.10 mm0.07 mm | Pass |
| Small | LengthMin 240 mmWidth$80 \pm 10$ mmThicknessFinger – min 0.05mmPalm - min 0.05mm | Length249 mmWidth87.0 mmThickness0.10 mm0.07 mm | Pass | |||
| Medium | LengthMin 240 mmWidth$95 \pm 10$ mmThicknessFinger – min 0.05mmPalm - min 0.05mm | Length249 mmWidth98.0 mmThickness0.10 mm0.07 mm | Pass | |||
| Large | LengthMin 240 mmWidth$110 \pm 10$ mm | Length248 mmWidth107 mm | Pass |
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| Thickness | Finger – min 0.05mmPalm - min 0.05mm | Thickness | 0.10 mm0.07 mm | Pass | ||||
|---|---|---|---|---|---|---|---|---|
| X-Large | Length | Min 240 mm | Length | 250 mm | Pass | |||
| Width | $120 \pm 10$ mm | Width | 117 mm | Pass | ||||
| Thickness | Finger – min 0.05mmPalm - min 0.05mm | Thickness | 0.10 mm0.07 mm | Pass |
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| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| Watertight | ASTM D5151(Standard TestMethod forDetection of Holesin Medical Gloves) | To detect holesthat leak waterand therebycompromise theusefulness of theglove. | Sample size: 500 pcsInspection level: G1AQL: 1.5, Acceptance No. 10 | The batch size for thissampling is 150,001 to500,000. Hence,according to the singlesampling plan GI, thesample to be drawn isunder code Mequivalent to 315pieces with accept 10and reject 11 to beaccepted under AQL1.5. During the test, 1piece was found withleaks. Hence it fallswithin the acceptancecriteria. | Pass |
| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| ResidualPowder | ASTM D6124(Standard TestMethod for ResidualPowder on MedicalGloves) | To determine theamount ofresidual powderand non-powdersolids found ongloves. | Less than 2 mg per glove | Sample size : 5 pcsRequirement : <2mg/gloveResult :0.24mg/glove | Pass |
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510(k) No: K210366
8.0 Summary of Clinical Testing:
No clinical study is included in this submission.
9.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrate that the subject Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K192333.
§ 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.