(99 days)
Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
The Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are powder-free Class I patient examination gloves are manufactured from nitrile and are blue in color. The examination gloves are intended for medical purpose, will be worn on the examiner's hand, and will be available in four sizes (Small, Medium, Large, and Extra-Large).
The provided document describes the acceptance criteria and the results of non-clinical testing for the Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves (K211515).
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method (Purpose) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM D 6319 Standard Specification for Nitrile Examination Gloves for Medical Application (To determine the length of the gloves) | Small: Min 220 mmMedium: Min 230 mmLarge: Min 230 mmExtra-Large: Min 230 mm | Pass |
| ASTM D 6319 Standard Specification for Nitrile Examination Gloves for Medical Application (To determine the width of the gloves) | Small: 80 ± 10 mmMedium: 95 ± 10 mmLarge: 110 ± 10 mmExtra-Large: 120 ± 10 mm | Pass |
| ASTM D 6319 Standard Specification for Nitrile Examination Gloves for Medical Application (To determine the Thickness of the gloves) | Min palm thickness: 0.05 mmMin finger thickness: 0.05 mm (for all sizes) | Pass |
| ASTM D 5151 Standard Test Method for Detection of Holes in Medical Gloves (To determine the presence of holes in the gloves) | AQL = 2.5 | Pass (Glove inspection passes at an AQL of 2.5) |
| ASTM D 6124 Standard Test Method for Residual Powder on Medical Gloves (To determine the residual powder content on the gloves) | ≤ 2 mg/glove | Pass |
| ASTM D 6319 Standard Specification for Nitrile Examination Gloves for Medical Application (To determine the tensile strength of the gloves) | Before Aging: Minimum of 14 MPa for all SizesAfter Aging: Minimum of 14 Mpa for all sizes | Pass |
| ASTM D 6319 Standard Specification for Nitrile Examination Gloves for Medical Application (To determine the ultimate elongation of the gloves) | Before Aging: Minimum of 500% for all sizesAfter Aging: Minimum of 400% for all sizes | Pass |
| Biocompatibility: Primary Skin Irritation per ISO 10993-10 (To determine if the finished device material is an irritant) | Not an irritant under the conditions of the study. | Pass |
| Biocompatibility: Dermal Sensitization per ISO 10993-10 (To determine if the finished device material is a sensitizer) | Not a sensitizer under the conditions of the study. | Pass |
| Biocompatibility: In Vitro Cytotoxicity per ISO 10993-5 (To determine if the finished device material is cytotoxic) | Non-cytotoxic under the conditions of the study. (Note: The predicate device listed "cytotoxic. Additional testing performed to determine if this was a systemic toxicity concern." The subject device listed "cytotoxic at elevated test article extracts. Additional analysis was performed to determine if this was a systemic toxicity concern. Non-cytotoxic at 25% test article extract.") | Non-cytotoxic at 25% test article extract. |
| Biocompatibility: Acute Systemic Toxicity Test per ISO 10993-11 (To determine if the finished device material extracts pose a systemic toxicity concern) | Device extracts do not pose a systemic toxicity concern under the conditions of the study. | Pass |
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 specific sample sizes used for each non-clinical test. It refers to compliance with ASTM and ISO standards, which typically specify sampling plans. The data provenance is implied to be from the manufacturer's testing of the subject device (Beijing Reagent Latex Products Co., Ltd.), which is located in Beijing, China. The testing appears to be prospective as it was conducted for this specific 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the non-clinical tests described. The ground truth for these tests is established by objective physical and chemical testing methods as defined by the ASTM and ISO standards, rather than expert consensus on medical images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to the non-clinical tests described. Adjudication methods are typically used for subjective assessments or when discrepancies arise in expert interpretations of medical data, which is not the case here.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document states, "This section is not applicable to this Premarket Notification 510(k); there was no clinical testing conducted on this product." This device is a medical glove, and its performance is evaluated through physical and biocompatibility testing, not through AI assistance for human readers.
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 medical glove, not an algorithm or AI-based diagnostic tool. Its performance is entirely standalone in its physical and biological properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for these non-clinical tests is based on objective measurements and standardized testing protocols defined by international standards (ASTM and ISO). For example:
- Physical properties (length, width, thickness, tensile strength, elongation) are determined by direct measurement.
- Hole detection is determined by water leak testing.
- Powder residue is determined by gravimetric analysis.
- Biocompatibility tests (skin irritation, sensitization, cytotoxicity, systemic toxicity) are performed in vitro or in vivo according to specified biological testing methods, and the results are compared against defined biological responses.
8. The sample size for the training set
This information is not applicable. The device is a physical product (medical glove), not a machine learning model 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 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.
August 24, 2021
Beijing Reagent Latex Products Co., Ltd. % Stephen Beier Head of Regulatory Affairs and Quality Systems Bayside Life Science Consultants, LLC 252 Nassau Street, Floor 2 Princeton, New Jersey 08542
Re: K211515
Trade/Device Name: Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 21, 2021 Received: August 5, 2021
Dear Stephen Beier:
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.
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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 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 Clarence W. Murray III, 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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Indications for Use
510(k) Number (if known) K211515
Device Name
Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves
Indications for Use (Describe)
Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are disposable devices intended for medical purpose that are 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
(K211515)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Beijing Reagent Latex Products Co., Ltd. Address: No. 6 Xingguang 5th Street Opto-Mechatronics Industrial Park Beishenshu Village Est, Taihu Town Tongzhou District, Beijing, China 101111 Phone Number: +86-10-81502524 Contact: HaiTao Liu, Export Manager Date of Preparation: July.30,2021
Designated Submission Correspondent
Stephen Beier, Head of Regulatory Affairs & Quality Systems Bayside Life Science Consultants, LLC 252 Nassau Street, Floor 2 Princeton, NJ 08542 Tel: +1-800-881-2063 Email: stephen@baysideops.com
2.0 Device Information
Trade name: Snow Lotus Nitrile Examination Gloves Common name: Nitrile Examination Gloves Classification name: Non-powdered patient examination gloves Model(s): S, M, L, XL
3.0 Classification
Production code: LZA, Requlation number: 21 CFR 880,6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: Beijing Reagent Latex Products Co., Ltd. Device: Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves 510(k) number: K211515
5.0 Device Description
The Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are powder-free Class I patient examination gloves are manufactured from nitrile and are blue in
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color. The examination gloves are intended for medical purpose, will be worn on the examiner's hand, and will be available in four sizes (Small, Medium, Large, and Extra-Large).
6.0 Indication for Use
Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
| Item | Predicate Device(K192333) | Subject Device(K211515) | Remark |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Intended Use | Blue Nitrile ExaminationGloves Powder Free isdisposable deviceintended for medicalpurpose that are wonon the examiner's handtoprevent contaminationbetween patient andexaminer. | Beijing Reagent LatexProducts Co., Ltd NitrileExamination Gloves aredisposable devicesintended for medicalpurpose that are worn onthe examiner's handto prevent contaminationbetween patient andexaminer. | Same |
| Dimensions(Length and Width)per ASTM D6319 | Length: Minimum 230mmWidth: Minimum 95+/-10mm (for medium sizedglove) | Length: Minimum 230 mmWidth: Minimum 95+/-10mm (for medium sizedglove) | Same |
| Thickness perASTM D6319 | Palm thickness:Minimum0.05 mmFinger thickness:Minimum0.05 mm | Palm thickness: Minimum0.05 mmFinger thickness: Minimum0.05 mm | Same |
| Physical PropertiesBefore Aging perASTM D6319 | Tensile Strength:Minimum 14 MPaUltimate Elongation:Minimum 500% | Tensile Strength:Minimum 14 MPaUltimate Elongation:Minimum 500% | Same |
| Physical PropertiesAfter Aging perASTM D6319 | Tensile Strength:Minimum 14 MPaUltimate Elongation:Minimum 400% | Tensile Strength:Minimum 14 MPaUltimate Elongation:Minimum 400% | Same |
| Water tight (holedetection) perASTM D5151 | Passes at AQL of 2.5 | Passes at AQL of 2.5 | Same |
| Powder Residueper ASTM D6319 | ≤ 2 mg/glove | ≤ 2 mg/glove | Same |
| Biocompatibility:Primary SkinIrritation per ISO10993-10 | Not an irritant under theconditions of the study. | Not an irritant under theconditions of the study. | Same |
| Biocompatibility:DermalSensitizationper ISO 10993-10 | Not a sensitizer undertheconditions of the study. | Not a sensitizer under theconditions of the study. | Same |
| Biocompatibility: InVitro Cytotoxicityper ISO 10993-5 | Under the conditions ofthe study, cytotoxic.Additional testingperformed to determine ifthis was a systemictoxicity concern. | Under the conditions of thestudy, cytotoxic atelevated test articleextracts. Additionalanalysis was performed todetermine if this was asystemic toxicity concern.Non-cytotoxic at 25% testarticle extract. | Similar |
| Biocompatibility:Acute SystemicToxicity Test perISO 10993-11 | Device extracts do notpose a systemic toxicityconcern under theconditions of the study. | Device extracts do notpose a systemic toxicityconcern under theconditions of the study. | Same |
| Device Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Size Offering | Extra-Small, Small, | Small, Medium, Large, | Different |
| Medium, Large, Extra-Large | Extra- Large | (no ExtraSmall sizeoffered) | |
| Number of Uses | Single Use | Single Use | Same |
7.0 Technological Characteristic Comparison Table
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Analysis: There are no significant differences between the subject device and its predicate device, and the two are identical in terms of intended use, materials, design, and performance specifications. Both the predicate device under K192333 as well as the subject device are compliant with ASTM D6319.
8.0 Summary of Non-Clinical Testing
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D 6319 StandardSpecification for NitrileExamination Gloves forMedical Application | ASTM D 6319 StandardSpecification for NitrileExamination Gloves forMedical Application | Small: Min 220 mmMedium: Min 230 mmLarge: Min 230 mmExtra-Large: Min 230 mm | Pass |
| ASTM D 6319 StandardSpecification for NitrileExamination Gloves forMedical Application | To determine thewidth of the gloves. | Small: 80 ± 10 mmMedium: 95 ± 10 mmLarge: 110 ± 10 mmExtra-Large: 120 ± 10 mm | Pass |
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| ASTM D 6319 StandardSpecification for NitrileExamination Gloves forMedical Application | To determine theThickness of the gloves. | Min palm thickness: 0.05 mmMin finger thickness: 0.05 mm(for all sizes) | Pass |
|---|---|---|---|
| ASTM D 5151 StandardTest Method forDetection of Holes inMedical Gloves | To determine thepresence of holes inthe gloves. | AQL = 2.5 | Gloveinspectionpasses at anAQL of 2.5 |
| ASTM D 6124 StandardTest Method forResidual Powder onMedical Gloves | To determine theresidual powdercontent on thegloves. | ≤ 2 mg/glove | Pass |
| ASTM D 6319 StandardSpecification for NitrileExamination Gloves forMedical Application | To determine thetensile strength of thegloves. | Before AgingMinimum of 14 MPa for all SizesAfter AgingMinimum of 14 Mpa for all sizes | Pass |
| ASTM D 6319 StandardSpecification for NitrileExamination Gloves forMedical Application | To determine theultimate elongation ofthe gloves. | Before AgingMinimum of 500% for all sizesAfter AgingMinimum of 400% for all sizes | Pass |
| Biocompatibility:Primary Skin Irritationper ISO 10993-10 | To determine if thefinished devicematerial is an irritant. | Not an irritant under theconditions of the study. | Pass |
| Biocompatibility:Dermal Sensitizationper ISO 10993-10 | To determine if thefinished devicematerial is a sensitizer. | Not a sensitizer under theconditions of the study. | Pass |
| Biocompatibility: InVitro Cytotoxicity perISO 10993-5 | To determine if thefinished devicematerial is cytotoxic. | Non-cytotoxic under theconditions of the study. | noncytotoxicat 25% testarticle extract. |
| Biocompatibility: AcuteSystemic Toxicity Testper ISO 10993-11 | To determine if thefinished devicematerial extractspose a systemictoxicity concern | Device extracts do not pose asystemic toxicity concern underthe conditions of the study. | Pass |
9.0 Summary of Clinical Testing
This section is not applicable to this Premarket Notification 510(k); there was no clinical testing conducted on this product.
10.0 Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K211515, Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under 510(k) 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.