(87 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in six sizes: XS, S, M, L, XL, XXL. The subject device is non-sterile.
This document describes the safety and performance of Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) as submitted for FDA 510(k) clearance (K213048). The study focuses exclusively on comprehensive bench testing and biocompatibility assessments, demonstrating the device's adherence to established standards for medical gloves, particularly regarding chemotherapy drug permeation.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm):XS: ≥220;S/M/L/XL/XXL: ≥230Width (mm):XS: 70±10;S: 80±10;M: 95±10;L: 110±10;XL: 120±10;XXL: 130±10Thickness (mm):Finger: ≥0.05;Palm: ≥0.05 | Length (mm):All sizes: > 240/PassWidth (mm):XS: 80-83/PassS: 86-90/PassM: 97-98/PassL: 108-112/PassXL: 115-120/PassXXL: 128-130/PassThickness (mm):Finger: 0.08-0.10/PassPalm: 0.08-0.11/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass (This implies that out of 125 samples tested, 0 failed, meeting AQL 2.5) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.03mg/Pass |
| ASTM D412 | Physical properties (Before Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥500% | Tensile Strength: 15.1-16.9MPa/PassUltimate Elongation: 536-559%/Pass |
| ASTM D412 | Physical properties (After Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥400% | Tensile Strength: 16.0-18.0MPa/PassUltimate Elongation: 540-553%/Pass |
| ISO 10993-5 | Cytotoxicity | Non- In Vitro Cytotoxicity | Under conditions of the study, device extract is not cytotoxic. /Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant. / Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. / Pass |
| ASTM D6978-05 (Chemotherapy Drug Permeation) | Assessment of Resistance to Permeation by Chemotherapy Drugs | Breakthrough Detection Time for specific drugs to meet or exceed established benchmarks. The established benchmark is typically >240 minutes for many drugs, but lower times are accepted for certain highly permeable drugs, provided they are clearly labeled with warnings. | Carboplatin: > 240 MinutesCarmustine (BCNU): 26.5 Minutes (Warning advised)Cyclophosphamide: > 240 MinutesDoxorubicin: > 240 MinutesEtoposide: > 240 MinutesFluorouracil: > 240 MinutesMethotrexate: > 240 MinutesPaclitaxel: > 240 MinutesThioTepa: 48.4 Minutes (Warning advised) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of units (gloves) for each test, but it does refer to meeting ASTM standards, which would imply a scientifically sound sampling methodology.
For the Watertightness Test, the results state "0/125/Pass," indicating a sample size of 125 units was tested for holes.
The data provenance is based on non-clinical laboratory testing (bench testing) performed by or for Huayuan Medical Technology (Shangqiu) Co., Ltd. The specific location of testing is not detailed beyond the company's address in Shangqiu City, Henan Province, China. The data would be considered prospective for the purposes of this 510(k) submission, as these tests were conducted to demonstrate compliance for the specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on objective, standardized bench tests (e.g., ASTM, ISO standards) to establish performance. The "ground truth" is defined by the technical specifications and criteria outlined in these industry-recognized standards, rather than expert consensus on subjective data (like image interpretation in AI/clinical studies). No human experts were used to establish ground truth in the context of clinical/radiological assessment. The experts involved would be laboratory technicians and engineers qualified to perform and interpret the specified physical, chemical, and biological tests according to the standards.
4. Adjudication Method for the Test Set
Not applicable. Since the study involves objective bench testing against pre-defined acceptance criteria from international standards (ASTM, ISO), no human adjudication of test results is typically required beyond standard quality control and verification procedures of the testing laboratory.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This K213048 submission is for Nitrile Patient Examination Gloves, which are a physical medical device, not a diagnostic imaging AI system. Therefore, an MRMC comparative effectiveness study, which is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, was not performed. The study focuses on the physical and chemical properties of the gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
Not applicable. This is not an AI-powered diagnostic device or software. The "performance" being assessed is the physical and chemical resistance of the gloves, which is inherently a standalone performance of the material and manufacturing process under controlled laboratory conditions.
7. The Type of Ground Truth Used
The "ground truth" for this device is established by objective laboratory measurements against pre-defined technical specifications and performance criteria set forth in internationally recognized standards (ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ASTM D6978-05, ISO 10993-5, ISO 10993-10). For example, the ground truth for "tensile strength" is a measured force in MPa, which is then compared to an acceptance criterion (e.g., ≥14MPa). For chemotherapy drug permeation, the ground truth is the measured breakthrough time in minutes.
8. The Sample Size for the Training Set
Not applicable. This is a traditional medical device (gloves), not an AI/machine learning model. Therefore, there is no "training set." The manufacturing process for physical gloves does not involve machine learning training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a physical device like examination gloves.
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December 18, 2021
Huayuan Medical Technology(Shangqiu) Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K213048
Trade/Device Name: Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: September 16, 2021 Received: September 22, 2021
Dear Boyle Wang:
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
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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,
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) K213048
Device Name
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carboplatin | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 26.5 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Doxorubicin | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 Minutes |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 Minutes |
| ThioTepa | 10.0 mg/ml(10,000 ppm) | 48.4 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 26.5 Minutes ThioTepa 10.0 mg/ml 48.4 Minutes
Warning: Please do not use with Carmustine (BCNU) and ThioTepa.
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 K213048
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Huayuan Medical Technology (Shangqiu) Co., Ltd. Name: Address: In The North Yard of West 1000m Road At The Intersection of Zhuangzhou Avenue and Pingyuan Road, Liangyuan District, Shangqiu City, Henan Province, China Contact: Huamei Wang Date of Preparation: Sept 16, 2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 Lujiazui East Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Nitrile Patient Examination Gloves (Tested for Use with Trade name: Chemotherapy Drugs) Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS, S, M, L, XL, XXL
3.0 Classification
Production code: LZA,LZC Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: Ever Growth (Vietnam) Co., Ltd. Device: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Disposable Powder Free
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Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color
510(k) number: K190860
5.0 Device Description
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in six sizes: XS, S, M, L, XL, XXL. The subject device is non-sterile.
6.0 Indication for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs
| Chemotherapy Drug | Concentration | Breakthrough DetectionTime in Minutes |
|---|---|---|
| Carboplatin | 10.0 mg/ml(10,000 ppm) | > 240 |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 26.5 |
| Cyclophosphamide(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Doxorubicin | 2.0 mg/ml(2,000 ppm) | > 240 |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | > 240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 |
| ThioTepa | 10.0 mg/ml(10,000 ppm) | 48.4 |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 26.5 Minutes; Thio Tepa 10.0 mg/ml 48.4 Minutes.
Warning: Please do not use with Carmustine (BCNU) and ThioTepa.
7.0 Technological Characteristic Comparison Table
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| Item | Subject Device(K213048) | Predicate Device(K190860) | Remark |
|---|---|---|---|
| Product Code | LZA,LZC | LZA,LZC | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | A patient examinationgloves is a disposabledevice intended for medicalpurpose that is worn on theexaminer's hand orfingers to preventcontamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 StandardPractice for Assessment ofMedical gloves toPermeation byChemotherapy Drugs. | A patient examinationgloves is a disposabledevice intended for medicalpurpose that is worn on theexaminer's hand orfingers to preventcontamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 StandardPractice for Assessment ofMedical gloves toPermeation byChemotherapy Drugs. | Same |
| Powdered or Poweredfree | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Labeling Information | Single-use indication,powder free, device color,device name, glove size andquantity,Non-Sterile, astatement of standardASTM D6978-05compliance and asummary of the testingresults. | Single-use indication,powder free, device color,device name, glove sizeand quantity, Non-Sterile, astatement of standardASTM D6978-05compliance and asummary of the testingresults. | Same |
| Dimensions(mm) | Length:XS:≥220;S/M/L/XL/XXL: ≥230;Width:XS: 70±10;S: 80±10;M: 95±10;L: 110±10;XL: 120±10 | Length:XS/S/M/L/XL: ≥230;Width:XS:70±10;S: 80±10;M: 95±10;L: 110±10;XL: 120±10 | Similar |
Table1-General Comparison
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| XL: 120±10;XXL: 130±10 | ||||||
|---|---|---|---|---|---|---|
| Thickness(mm) | Finger: ≥0.05;Palm: ≥0.05 | Finger: ≥0.05;Palm: ≥0.05 | Same | |||
| Colorant | Blue | White, Orange | Different | |||
| PhysicalProperties | BeforeAging | TensileStrength | 14MPa, min | Tensile Strength | 14MPa, min | Same |
| UltimateElongation | 500% min | Ultimate Elongation | 500% min | Same | ||
| AfterAging | TensileStrength | 14MPa, min | Tensile Strength | 14MPa, min | Same | |
| UltimateElongation | 400%min | Ultimate Elongation | 400%min | Same | ||
| Freedom from Holes | Be free from holes whentested in accordance withASTMD5151 AQL=2.5 | Be free from holes whentested in accordance withASTMD5151 AQL=2.5 | Same | |||
| Powder Content | 0.03 mg per glove, Meetthe requirements ofASTM D6124 | Meet the requirements ofASTM D6124 | Similar | |||
| Biocompatibility | ISO 10993-10;Under the conditions ofthe study, not an irritantor a sensitizerISO 10993-5Under conditions of thestudy, device extract isnot cytotoxic | ISO 10993-10;Under the conditions ofthe study, not an irritantor a sensitizerISO 10993-5Under conditions of thestudy, device extract isnot cytotoxic | Same | |||
| Carboplatin 10.0 mg/ml:> 240 Minutes | / | Different | ||||
| Carmustine (BCNU) 3.3mg/ml: 26.5 Minutes | Carmustine (BCNU) 3.3mg/ml:White:11.8 Minutes;Orange:31.6Minutes | Similar | ||||
| / | Cisplatin 1.0 mg/ml: >240Minutes | Different | ||||
| Cyclophosphamide(Cytoxan) 20.0 mg/ml:> | Cyclophosphamide(Cytoxan) | Same |
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| Chemotherapy DrugsTested with MinimumBreakthroughDetection Time asTested per ASTM D6978 | 240 Minutes/ | 20.0 mg/ml: >240 MinutesDacarbazine (DTIC) 10.0mg/ml:>240 Minutes | Different |
|---|---|---|---|
| Doxorubicin 2.0 mg/ml: >240 Minutes | Doxorubicin Hydrochloride2.0mg/ml: >240 Minutes | Same | |
| Etoposide 20.0 mg/ml: >240 Minutes | Etoposide (Toposar) 20.0mg/ml: >240 Minutes | Same | |
| Fluorouracil 50.0 mg/ml: >240 Minutes | Fluorouracil 50.0 mg/ml: >240Minutes | Same | |
| Methotrexate25.0mg/ml(25,000 ppm): >240 /Minutes | / | Different | |
| Paclitaxel 6.0 mg/ml: >240Minutes | Paclitaxel (Taxol) 6.0mg/ml:>240 Minutes | Same | |
| ThioTepa 10.0 mg/ml: 48.4Minutes | Thio-Tepa 10.0 mg/ml:White:16.9 Minutes;Orange: 72.5 Minutes | Similar |
8.0 Summary of Non-Clinical Testing
Biocompatibility Testing
The biocompatibility evaluation for Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) was conducted in accordance with the following standards:
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization.
ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
Performance Testing (Bench)
Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Permeation testing was conducted to support the addition of the labeling claim:
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Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs.
In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for -Residual Powder on Medical Gloves
- -ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| TestMethod | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTMD6319 | PhysicalDimensionsTest | Length(mm):XS: ≥220; | Length(mm):> 240/Pass; |
| S/M/L/XL/XXL: ≥230; | Width(mm): | ||
| Width(mm):XS: 70±10; | XS: 80-83/Pass | ||
| S: 80±10; | S: 86-90/Pass | ||
| M: 95±10; | M: 97-98/ Pass | ||
| L: 110±10; | L: 108-112/ Pass | ||
| XL: 120±10; | XL:115-120/ Pass | ||
| XXL: 130±10 | XXL: 128-130/ Pass | ||
| Finger: ≥0.05; | Thickness (mm): | ||
| Palm: ≥0.05 | Finger: 0.08-0.10/PassPalm: 0.08-0.11/Pass | ||
| ASTMD5151 | WatertightnessTestforDetectionof | Meet the requirements of ASTM D5151AQL 2.5 | 0/125/Pass |
Table 2 - Summary of non-clinical performance testing
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| Holes | |||||
|---|---|---|---|---|---|
| ASTMD6124 | PowderContent | Meet the requirements of ASTM D6124 < 2.0mg | 0.03mg/Pass; | ||
| ASTMD412 | Physicalproperties | BeforeAging | TensileStrength | ≥14MPa | 15.1-16.9MPa/Pass; |
| UltimateElongation | ≥500% | 536-559%/Pass; | |||
| AfterAging | TensileStrength | ≥14MPa | 16.0-18.0MPa/Pass; | ||
| UltimateElongation | ≥400% | 540-553%/Pass; | |||
| ISO10993-5 | Cytotoxicity | Non- In Vitro Cytotoxicity | Under conditions of the study, device extract is not cytotoxic. /Pass | ||
| ISO10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant. / Pass | ||
| ISO10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. / Pass |
9.0 _Summary of Clinical Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K190860.
§ 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.