(83 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010). The gloves are non-sterile, ambidextrous and single-use disposable devices that come in five sizes (XS, S, M, L, XL).
This document describes the acceptance criteria and performance of the "Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim".
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standards Requirements) | Reported Device Performance (Results Summary) |
|---|---|---|
| Dimensions | ASTM D 3578-05 (2010): Length ≥ 270mm, Palm Thickness ≥ 0.20mm, Finger Thickness ≥ 0.25mm, Width (X-Small 70-80mm, Small 80-90mm, Medium 90-100mm, Large 101-111mm, X-Large ≥ 111mm) | Meets Standard Requirements (Specific values provided in the submission align with or exceed criteria.) |
| Physical Properties (Tensile Strength, Elongation) | ASTM D 3578-05 (2010): Before Aging: Tensile Strength ≥ 18 MPA, Elongation ≥ 650%; After Aging: Tensile Strength ≥ 14 MPA, Elongation ≥ 500% | Meets Standard Requirements (Specific results provided in the submission align with or exceed criteria.) |
| Freedom from Pinholes | ASTM D 5151-11, ASTM D 3578-05 (2010): Pass quality level at G1 AQL 1.5 | Meets Standard Requirements (Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5.) |
| Powder Free Residue | ASTM D 6124-11, ASTM D 3578-05 (2010): ≤ 2 mg of residual powder per glove | Meets Standard Requirements (Result generated values ≤ 2 mg of residual powder per glove.) |
| Protein Content | ASTM D 5712-10, ASTM D 3578-05 (2010): ≤ 50 microgram/dm² | Meets Standard Requirements (Result generated values ≤ 50 microgram/dm².) |
| Biocompatibility | Dermal Sensitization (as ISO 10993-10:2010), Primary Skin Irritation Test (as ISO 10993-10:2010) | Meets Standard Requirements (Not a contact skin sensitizer, Not a primary skin irritant.) |
| Chemotherapy Drugs Permeation Test Method | ASTM D6978-05 | Meets Standard Requirements (Tested for Use with Chemotherapy Drugs. Specific breakthrough times are listed for 15 drugs, with Carmustine and Thiotepa noted as having extremely short permeation times of 15.4 and 30.6 minutes, respectively.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of image or algorithmic data. Instead, it details various laboratory tests performed on the physical glove product. The sample sizes for each specific test (e.g., dimensions, physical properties, pinholes, protein content, biocompatibility, chemotherapy permeation) are not explicitly stated in the provided summary. However, it is implied that testing was conducted in accordance with the relevant ASTM and ISO standards, which typically prescribe minimum sample sizes for statistical validity.
Data Provenance: The data provenance is from laboratory testing performed by Top Calibre Sdn Bhd (Malaysia) or a contracted lab under their supervision, to demonstrate compliance with international standards (ASTM, ISO). This is retrospective data collected as part of the device's development and regulatory submission process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This device is a physical product (medical glove), and the evaluation is based on laboratory performance against defined physical and chemical standards, not on expert interpretation of observational data or images. Therefore, clinical ground truth established by experts is not applicable.
4. Adjudication Method for the Test Set
N/A. As the evaluation is based on objective laboratory measurements against predefined standards, there is no need for an adjudication method as would be used in a clinical study with subjective interpretations.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
N/A. This is a physical product (glove) and not an AI or imaging device, so MRMC studies are not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
N/A. This is a physical product and does not involve an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is established by:
- International Standards: Primarily ASTM (American Society for Testing and Materials) standards (D3578-05, D5151-11, D6124-11, D5712-10, D6978-05) and ISO (International Organization for Standardization) standards (10993-10:2010) for physical, chemical, and biocompatibility properties. These standards define the acceptable range or threshold for each characteristic.
- Direct Measurement/Testing: Laboratory measurements and assays were conducted to determine the actual performance values of the gloves (e.g., tensile strength, breakthrough time for chemotherapy drugs). These measurements are then compared directly to the specified acceptance criteria within the standards.
8. Sample Size for the Training Set
N/A. This is a physical product and does not involve AI or machine learning algorithms that would require a training set.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set for an algorithm, this question is not applicable.
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K123819
MAR 0 5 2013
FDA 510(k), Premarket Notification: 510(k) Summary of Safety and Effectiveness Information
Date: 01 March 2013
1.0 Submitter:
Top Calibre Sdn Bhd 1-1, 2, Jalan Setia Prima U13/S Setia Alam, Seksyen U13, 40170 Shah Alam, Selangor, Malaysia
| Telephone No .: | +603 3291 0516 |
|---|---|
| Fax No .: | +603 3291 0542 |
2.0 Contact Person:
| Contact: | Ms Rosnita Maodin |
|---|---|
| Telephone No.: | +603 3291 0516 |
| Fax No .: | +603 3291 0542 |
3.0 Name of Device:
Trade Name: Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm- of glove or Less of Water Extractable Protein)
Common Name : Patient Examination Glove Classification Name : Patient Examination Glove Regulation Number : 21 CFR 880.6250 Classification Number: Class I Product Code : 80 LYY, 80 LZC
4.0 Identification of the Legally Marketed Device:
Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm of glove or Less of Water Extractable Protein), Class I patient examination gloves, Latex - 80 LY Y, Specialty - 80 LZC, meets all of the requirements of ASTM D3578-05 (2010) Standard Specification for Rubber Examination Glove.
Predicate Device: K083409, Powder Free Blue Latex Patient Examination Glove, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50 ug/dm2 per glove of Extractable Protein).
Page 1 of 7 (Rev 3)
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5.0 Description of Device:
Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).
The gloves are non-sterile, ambidextrous and single-use disposable devices that come in five sizes (XS, S, M, L, XL).
6.0 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 to prevent contamination between patient and examiner.
This glove has been tested for use with specific chemotherapy drugs listed below.
| Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes) |
|---|
| ------------------------------------------------------------------------------- |
| Carmustine (BCNU) (3.3 mg/ml) | 15.4 |
|---|---|
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Cytarabine (100 mg/ml) | > 240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Ifosfamide (50.0 mg/ml) | > 240 |
| Methotrexate (25 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 30.6 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
Please note that the following drugs - Carmustine and Thiotepa have extremely short permeation times of 15.4 and 30.6 minutes, respectively.
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7.0 Summary of the Technological Characteristics of the Device:
Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) possesses the following technological characteristic (as compared to ASTM or equivalent standards):
| Characteristic | StandardsRequirements | Results Summary | Conclusions |
|---|---|---|---|
| Dimensions | ASTM D 3578-05(2010) | Length≥ 270mmPalm Thickness≥ 0.20mmFinger Thickness≥ 0.25mmWidthX-Small 70-80mmSmall 80-90mmMedium 90-100mmLarge 101-111mmX-Large ≥ 111mm | MeetsStandardRequirements |
| PhysicalProperties | ASTM D 3578-05(2010) | Before Aging After AgingTensile Strength≥ 18 MPA ≥ 14 MPAElongation≥ 650% ≥ 500% | MeetsStandardRequirements |
| Freedom frompinholes | ASTM D 5151-11ASTM D 3578-05(2010) | Tested in accordance with ASTM D5151 testmethod. Pass quality level at G1 AQL 1.5 | MeetsStandardRequirements |
| Powder FreeResidue | ASTM D 6124-11ASTM D 3578-05(2010) | Result generated values ≤ 2 mg of residual powderper glove | MeetsStandardRequirements |
| Protein Content | ASTM D 5712-10ASTM D 3578-05(2010) | Result generated values ≤ 50 microgram/dm2 | MeetsStandardRequirements |
| Biocompatibility | Dermal Sensitization(as ISO 10993-10:2010)Primary Skin IrritationTest (as ISO 10993-10:2010) | Not a contact skin sensitizerNot a primary skin irritant | MeetsStandardRequirements |
| ChemotherapyDrugsPermeation TestMethod | ASTM D6978-05 | Chemotherapy Drug Permeation(Minimum Breakthrough Detection Time in Minutes)Carmustine (3.3 mg/ml) 15.4Cisplatin (1.0 mg/ml) >240Cyclophosphamide (20.0 mg/ml) >240Cytarabine (100 mg/ml) >240Dacarbazine (DTIC) (10.0 mg/ml) >240Doxorubicin Hydrochloride(2.0 mg/ml) >240Etoposide (20.0 mg/ml) >240Fluorouracil (50.0 mg/ml) >240Ifosfamide (50.0 mg/ml) >240Methotrexate (25 mg/ml) >240Mitomycin C (0.5 mg/ml) >240Mitoxantrone (2.0 mg/ml) >240Paclitaxel (Taxol) (6.0 mg/ml) >240Thiotepa (10.0 mg/ml) 30.6Vincristine Sulfate (1.0 mg/ml) >240 | Tested for UsewithChemotherapyDrugs.Carmustineand Thiotepahaveextremelyshortpermeationtimes of 15.4and 30.6minutes,respectively. |
Page 3 of 7 (Rev 3)
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8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm of glove or Less of Water Extractable Protein) has been tested against the applicable ASTM standards listed above, and meet the requirements set forth in those standards.
There is no different between the proposed device and the predicate with respect to performance standard and technological characteristics.
The predicate device was tested for nine drugs, while proposed device tested for 15 drugs. Respective drug's permeation result is shown in Indication for Use of the proposed device. The different in labeling (with additional drugs tested, exceed ASTM D6978-05 requirements), and in Indications for Use (with permeation results added) does not affect the safety and effectiveness of the proposed device.
9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data Clinical data is not needed for market cleared examination gloves.
10.0 Conclusion
It can be concluded that the Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm- of glove or Less of Water Extractable Protein), is as safe and effective as, the current legally marketed device identified in this 510(k) summary.
The Substantial Equivalent Comparison Table below outlines the similarity, and/or differences between the proposed device and the predicate device for the substantial equivalent determination.
The gloves are Substantial Equivalent to predicate device cleared under 510(k) K083409.
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Substantial Equivalent Comparison Table
| Characteristics | Predicate Device | Proposed Device |
|---|---|---|
| K083409, Powder Free BlueLatex Patient ExaminationGlove, Tested for use withChemotherapy Drugs with aProtein Content Label Claim( $≤50 ug/dm²$ per glove ofExtractable Protein) | Powder Free Latex PatientExamination Glove, Blue, Testedfor Use with Chemotherapy Drugs,with Protein Content LabelingClaim (Contains 50 Microgramsper dm² of glove or less of WaterExtractable Protein) | |
| DeviceDescription/RegulationNumber | Patient Examination Glove/21 CFR Part 880.6250 | Substantial Equivalent |
| Product Code | 80 LYY, 80 LZC | Substantial Equivalent |
| Intended Use | Intended for medical purposesthat is worn on the examiner'shand to prevent contaminationbetween patient and examiner. | Substantial Equivalent |
| Characteristics | Predicate Device | Proposed Device |
| K083409, Powder Free BlueLatex Patient ExaminationGlove, Tested for use withChemotherapy Drugs with aProtein Content Label Claim(≤50 ug/dm² per glove ofExtractable Protein) | Powder Free Latex PatientExamination Glove, Blue, withProtein Content and ChemotherapyDrugs Labeling Claim (Contains50 Micrograms per dm² of glove orless of Water Extractable Protein) | |
| Indications for Use | The powder free chemotherapyexamination glove is a specialtymedical. glove which is adisposable device intended formedical purposes that is wornon the examiner's hand orforefinger to preventcontamination betweenexaminer and patient bodilyfluids, waste and environment.Tested for use withchemotherapy drugs. Testedchemotherapy drugs are asfollows [Cyclophosphamide,Carmustine, Thio-Tepa,Dacarbazine, DoxorubicinHydrochloride, 5-Fluorouracil,Cisplatin, Etoposide, andPaclitaxel]Warning: Do not use gloveswith Thio-tepa andCarmustine. | A patient examination glove is adisposable device intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patient andexaminer.This glove has been tested for usewith specific chemotherapy drugslisted below.Chemotherapy Drug Permeation(Minimum Breakthrough DetectionTime in Minutes)Carmustine (3.3 mg/ml) 15.4Cisplatin (1.0 mg/ml) >240Cyclophosphamide(20.0 mg/ml) >240Cytarabine (100 mg/ml) >240Dacarbazine (DTIC)(10.0 mg/ml) >240Doxorubicin Hydrochloride(2.0 mg/ml) >240Etoposide (20.0 mg/ml) >240Fluorouracil (50.0 mg/ml) >240Ifosfamide (50.0 mg/ml) >240Methotrexate (25 mg/ml) >240Mitomycin C (0.5 mg/ml) >240Mitoxantrone (2.0 mg/ml) >240Paclitaxel (Taxol) (6.0 mg/ml) >240Thiotepa (10.0 mg/ml) 30.6Vincristine Sulfate (1.0 mg/ml) >240Please note that the following drugs- Carmustine and Thiotepa haveextremely short permeation times of15.4 and 30.6 minutes, respectively. |
| Design | Ambidextrous, in differentsizes per ASTM D3578dimension requirement | Substantial Equivalent |
| Characteristics | Predicate Device | Proposed Device |
| Materials | Natural Rubber Latex | Substantial Equivalent |
| Color | Blue | Substantial Equivalent |
| PerformanceI. SterilityII. Freedomfrom holesIII. DimensionIV. PhysicalPropertiesV. Powder FreeResidueVI. ProteinContent | K083409, Powder Free BlueLatex Patient ExaminationGlove, Tested for use withChemotherapy Drugs with aProtein Content Label Claim( $\leq$ 50 ug/dm² per glove ofExtractable Protein) | Powder Free Latex PatientExamination Glove, Blue, withProtein Content and ChemotherapyDrugs Labeling Claim (Contains50 Micrograms per dm² of glove orless of Water Extractable Protein) |
| Not Applicable (Non-Sterile)Passes at AQL 1.5Meets ASTM D3578Meets ASTM D3578Meets $\leq$ 2 mg/gloveMeets $\leq$ 50 $\mu$ g/dm² | Substantial EquivalentPasses at AQL 1.5 (SubstantialEquivalent)Meets ASTM D3578 (SubstantialEquivalent)Meets ASTM D3578 (SubstantialEquivalent)Meets $\leq$ 2 mg/glove (SubstantialEquivalent)Meets $\leq$ 50 $\mu$ g/dm² (SubstantialEquivalent) | |
| Single Use | Yes | Substantial Equivalent |
| BiocompatibilityTest | Passes.i. Primary Skin Irritation Testii. Dermal Sensitization Test | Substantial EquivalentSubstantial Equivalent |
| Packaging | Packed in Dispenser Boxes | Substantial Equivalent |
| Labeling Claim | i. With Extractable ProteinContent Labeling Claimii. Chemotherapy DrugsLabeling Claim per ASTMD6978-05 | Substantial Equivalent |
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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5, 2013
Ms. Rosnita Maodin Quality Assurance Manager Top Calibre Sdn Bhd 1-1, 2, Jalan Setia Prima U13/S Setia Alam, Seksyen U13 Shah Alam, Selangor Malaysia 40170
Re: K123819
Trade/Device Name: Powder Free Latex Patient Examination Glove, Blue Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Glove
Regulatory Class: I
Product Code: LYY, LZC Dated: January 30, 2013
Received: February 4, 2013
Dear Ms. Moadin:
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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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Page 2 - Ms. Maodin
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/8/Picture/6 description: The image shows a logo or emblem with stylized text and geometric shapes. The text appears to be handwritten and somewhat illegible, possibly reading "For" at the top left, with other words like "with" and "without" incorporated into the design. The geometric shapes include a maze-like pattern on the left and a triangular structure on the right, giving the logo a complex and abstract appearance. The overall design is black and white and has a rough, hand-drawn quality.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Powder Free Latex Patient Examination Glove, Blue Tested for Use with Chemotherapy Drugs, with Protein Content labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)
Indications for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes)
| Carmustine (BCNU) (3.3 mg/ml) | 15.4 |
|---|---|
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Cytarabine (100 mg/ml) | > 240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Ifosfamide (50.0 mg/ml) | > 240 |
| Methotrexate (25 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 30.6 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
Please note that the following drugs - Carnustine and Thiotepa have extremely short permeation times of 15.4 and 30.6 minutes, respectively
AND/OR Prescription Use Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
| Elizabeth | |
|---|---|
| Claverie | |
| 2013.03.05 16:12:07 -05'00' |
(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices
510(k) Number: K123819
Page I of
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§ 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.