(226 days)
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination
The proposed device, Latex Surgeon's Gloves Powder Free with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound fromcontamination. The proposed device is made of' natural rubber latex, as per standard ASTM D35 77-09(2015). The classification is: Type I - gloves compounded primarily from natural rubber latex". The proposed device is Powder Free Latex Surgeon's Gloves, and variants of different sizes. All variants share the same color, creamy, white. The proposed device is sterilized either using Ethylene Oxide Sterilization or Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10-6 and place in a sterility maintenance package to ensure a shelf life of 3 years.
This document is a 510(k) Premarket Notification for Latex Surgeon's Gloves Powder Free with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Criteria | Specification as per ASTM D3577-09 Standard | Average Value of Subject Device (Reported Performance) | Device Complied? |
|---|---|---|---|
| Length | |||
| Size 5½ | Min 265mm | 282mm | Yes |
| Size 6 | Min 265mm | 282mm | Yes |
| Size 6½ | Min 265mm | 282mm | Yes |
| Size 7 | Min 265mm | 282mm | Yes |
| Size 7½ | Min 265mm | 282mm | Yes |
| Size 8 | Min 265mm | 282mm | Yes |
| Size 8½ | Min 265mm | 282mm | Yes |
| Size 9 | Min 265mm | 282mm | Yes |
| Width | |||
| Size 5½ | 70 ± 6mm | 71mm | Yes |
| Size 6 | 76 ± 6mm | 78mm | Yes |
| Size 6½ | 83 ± 6mm | 82mm | Yes |
| Size 7 | 89 ± 6mm | 90mm | Yes |
| Size 7½ | 95 ± 6mm | 95mm | Yes |
| Size 8 | 102 ± 6mm | 100mm | Yes |
| Size 8½ | 108 ± 6mm | 106mm | Yes |
| Size 9 | 114 ± 6mm | 112mm | Yes |
| Finger Thickness (All sizes) | Min 0.10mm | 0.20mm | Yes |
| Palm Thickness (All sizes) | Min 0.10mm | 0.16mm | Yes |
| Cuff Thickness (All sizes) | Min 0.10mm | 0.13mm | Yes |
| Tensile Strength Before aging (All sizes) | 24Mpa minimum | 26.5Mpa | Yes |
| Tensile Strength After aging (All sizes) | 18Mpa minimum | 21.0Mpa | Yes |
| Ultimate Elongation Before aging (All sizes) | 750% minimum | 860% | Yes |
| Ultimate Elongation After aging (All sizes) | 560% minimum | 725% | Yes |
| Stress at 500% before aging (All sizes) | 5.5 MPa Max | 2.6 Mpa | Yes |
| Pinhole AQL Before aging (All sizes) | Max 1.5 | 1.0 | Yes |
| Pinhole AQL After aging (All sizes) | Max 1.5 | 1.0 | Yes |
| Powder Residue (Powder-Free Glove) | < 2 mg/Glove | (Not explicitly stated in table, but compliance with ASTM D6124-06 implies meeting this) | Yes |
| Protein Content | 50 µg/dm² or less per glove | (Not explicitly stated in table, but compliance with ASTM D5712-15 and ASTM D6499-16 implies meeting this) | Yes |
| Biocompatibility (Irritation, Sensitization, Acute Systemic Toxicity) | Non-irritant, Non-Sensitizer and Non-Toxic | (Not explicitly stated in table, but compliance with ISO 10993-10 implies meeting this) | Yes |
| Sterility Assurance Level (SAL) | 10⁻⁶ | (Implied by sterilization methods; not in table) | Yes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not explicitly stated for each test (length, width, thickness, tensile strength, elongation, stress, pinhole). However, "Average Value of Subject Device" generally indicates testing was done on multiple samples.
- Data provenance:
- Country of origin: Testing was conducted by Lenora Glove Pvt. Ltd., located in Coimbatore, Tamil Nadu, India.
- Retrospective or prospective: The document describes "bench tests" performed to verify the device met specifications, which indicates prospective testing of the manufactured product.
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 device is not an AI/diagnostic device that typically involves expert ground truth establishment in the same way. The "ground truth" for the performance characteristics comes from established international and national standards (e.g., ASTM D3577-09, ASTM D5151-06, ISO 10993-10). These standards define the acceptable range for physical and biological properties of latex surgeon's gloves. Therefore, there were no "experts" in the context of medical image interpretation for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described above, the acceptance criteria are based on objective measurements against established engineering and medical device standards, not subjective interpretations 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 is a physical medical device (surgical glove), not an AI-assisted diagnostic tool or an imaging product. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is defined by the acceptance criteria established in recognized consensus standards. These standards (e.g., ASTM, ISO) outline specific physical, mechanical, and biological properties that surgical gloves must meet for safety and effectiveness.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used for this physical medical device.
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October 24, 2019
Lenora Glove PVT LTD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Drive Ste 114 Aurora, Illinois 60504
Re: K190632
Trade/Device Name: Latex Surgeon's Gloves Powder Free with protein content labeling claim of 50ug/dm2 or less per glove of extractable protein Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: September 18, 2019 Received: September 24, 2019
Dear Manoj Zacharias:
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 (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 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 Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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) K190632
Device Name
Latex Surgeon's Gloves Powder Free with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein
Indications for Use (Describe)
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination
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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LENORA GLOVE PVT.LTD. SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVE POWDER FREE
510K SUMMARY as required by: 21CFR § 807.92
A. APPLICANT INFORMATION
| 1. | Submitter Name | LENORA GLOVE PVT. LTD. |
|---|---|---|
| Date Submitted | September 18, 2019 | |
| Address | Plot No:15/104-1, Rottigoundanur,Thirumalayampalayam P.O., Coimbatore,Tamilnadu State, India-641 105 | |
| Phone | +91 422 2656 443, 2656 941 | |
| Fax | 1 (815) 986-2632 | |
| qa@lenoraglove.com | ||
| Contact Person | ANTONY KURIYAN | |
| Designation | Managing Director | |
| Contact Number | +91 974700797 | |
| Contact Email | qa@lenoraglove.com |
B. US AGENT & CONTACT PERSON INFORMATION
| US agent & contact person name | Manoj Zacharias |
|---|---|
| Address | Liberty Management Group Ltd.75 Executive Dr. STE 114, Aurora, IL-60504, USA. |
| Phone | (630) 270-2921 |
| Fax | (815) 986-2632 |
| manoj@libertymanagement.us |
C. DEVICE IDENTIFICATION
| Common Name | Surgeon's Glove |
|---|---|
| Device Name | Latex Surgeon's Glove powder free withprotein content labeling claim of 50 µg/dm²or less per glove of extractable protein |
| Product proprietary or tradename | Latex Surgeon's Glove powder free withprotein content labeling claim of 50 µg/dm²or less per glove of extractable protein |
| Classification name | Surgeon's Glove |
| Device Classification | 1 |
| Product Code | KGO |
| Regulation Number | 21 CFR 878.4460 |
| Review Panel | Gen & Plastic Surgery |
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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVE POWDER FREE
D.PREDICATE DEVICE INFORMATION
| Name of devices | 510k Number | 510K Owner | |
|---|---|---|---|
| Predicate device | “PRISTEEN” Latex Surgeon'sGlove powder free withprotein content labeling claimof 50 $µg/dm^2$ or less perglove of extractable protein | K172942 | Beta Health Care productsPvt.Ltd,Plot No 21B,Cochin Special EconomicZone,Kakkanad, kerala,India-682037 |
| Reference device | “Medismart+” Latex Surgeon'sGlove powder free withprotein content labeling claimof 50 $µg/dm^2$ or less perglove of extractable protein | K151114 | St.Marys Rubbers Pvt.Ltd,Koovappally P.O,Kanjirappally, KottayamDistrict, Kerala State,India-686518 |
E. DESCRIPTION OF THE DEVICE
The proposed device, Latex Surgeon's Gloves Powder Free with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound fromcontamination.
The proposed device is made of' natural rubber latex, as per standard ASTM D35 77-09(2015).
The classification is: Type I - gloves compounded primarily from natural rubber latex".
The proposed device is Powder Free Latex Surgeon's Gloves, and variants of different sizes.
All variants share the same color, creamy, white.
The proposed device is sterilized either using Ethylene Oxide Sterilization or Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 6and place in a sterility maintenance package to ensure a shelf life of 3 years.
F. INDICATION FOR USE
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVE POWDER FREE
G. TECHNOLOGICAL COMPARISON
a. General Characteristics Comparison
| Characteristic | Subject deviceK190632 | Predicate deviceK172942 | Reference deviceK151114 | Comparison |
|---|---|---|---|---|
| Product Code | KGO | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Class | 1 | 1 | 1 | Same |
| Intended Use forLatex Surgeon'sGloves PowderFree, with proteincontent labelingclaim of50µg/dm² or lessper glove ofextractableprotein. | A latex surgeon's glove is adevice made of naturalrubber intended to be wornby operating room personnelto protect a surgical woundfrom contamination. | A latex surgeonSurgeons glove isa device made ofnatural rubberintended to beworn byoperating roompersonnel toprotect a surgicalwound fromcontamination | A latex surgeonSurgeons glove isa device made ofnatural rubberintended to beworn byoperating roompersonnel toprotect a surgicalwound fromcontamination | Similar |
| Powdered orPowder free | Powder free | Powder free | Powder free | Same |
| Method ofpowder free | Polymer coat | same | same | Same |
| Classification perASTMD3577-99 | Type I - gloves compoundedprimarily from naturalrubber latex | Type I - glovescompoundedprimarily fromnatural rubberlatex | Type I - glovescompoundedprimarily fromnatural rubberlatex | Same |
| Sterilization | ETO/as well as Radiation,SAL- 10-6 | ETO/as well asRadiation,SAL- 10-6 | ETO/as well asRadiation,SAL- 10-6 | Same |
| Label andLabeling | Meet FDA's Requirements | Meet FDA'sRequirements | Meet FDA'sRequirements | Same |
| Special labelclaim | Protein content labelingclaim of 50 µg/dm² or lessper glove of extractableprotein for Latex Surgeon'sGloves Powder Free. | Same | Same | Same |
| Type of use | Over the counter use | Over the counteruse | Over the counteruse | Same |
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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVE POWDER FREE
| Characteristics | Acceptance criteria of the standard | |||
|---|---|---|---|---|
| Subject deviceK190632 | Predicate deviceK172942 | Reference deviceK151114 | Comparison | |
| Dimensions | ASTM D3577-09((Reapproved 2015)) | ASTM D3577 | ASTM D3577 | Similar |
| PhysicalProperties | ASTM D3577-09(Reapproved 2015) | ASTM D3577 | ASTM D3577 | Similar |
| Freedom fromHoles | ASTM D3577 andAST MD5151-06,(Reapproved 2015) | ASTM D3577 andAST M D5151 | ASTM D3577 andAST M D5151 | Similar |
| Powder residuefor powder freeglove | ASTM D3577 and ASTMD6124-06, (Reapproved2017)Powder content< 2 mg/Glove | ASTM D3577 andASTM D6124,Powder content< 2 mg/Glove | ASTM D3577 andASTM D6124,Powder content< 2 mg/Glove | Similar |
| Protein Content | ASTM D3577, ASTMD5712-15 and ASTMD6499-16 | ASTM D3577,ASTM D5712 andASTM D6499 | ASTM D3577,ASTM D5712 andASTM D6499 | Similar |
| Biocompatibility(Irritation,Sensitization,Acute SystemicToxicity) | ISO 10993-10Non- irritant,Non-Sensitizer and Non-Toxic | ISO 10993-10 | ISO 10993-10 | Similar |
Technological Characteristics Comparison b.
H. Summary of Non-Clinical Testing
Bench tests were conducted to verify that the proposed device met all design specifications as the predicate devices. The standards used in this submission and the test results demonstrated that the proposed device complies with the following standards:
- . ASTM D3577-09 (2015):- Standard Specification for Rubber Surgical Gloves.
- ASTM D 5151-06(2015):-Standard Test Method for Detection of Holes in . Medical Gloves.
- ASTM D6124-06(2017):-Standard Test Method for Residual Powder on . Medical Gloves.
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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVE POWDER FREE
- ASTM D5712-15:-Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
- . ASTM D6499-18:-Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products.
- . ASTM F 1929-2015:-Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
- . ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ISO 11137-1-2006/ (R) 2010 validation of sterilization process. ●
- ISO 11137-2:2013, Sterilization of health care products - radiation - part 2: establishing the sterilization dose
- 1S01137-2:2013: Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose.
- ISO 10993-7:2008:-Biological evaluation of medical devices --: Ethylene oxide ● sterilization residuals.
- . ISO 11135-1:2014 :- Sterilization of healthcare products -- Ethylene oxide -Part 1: Requirements for development, validation and routine control of a sterilization process for medicaldevices.
A summary of the non-clinical testing results for the subject device is provided below. The standards used in this submission and the test results demonstrate that the proposed device meets the acceptance criteria for the referenced standards.
| CRITERIA | SPECIFICATION AS | AVERAGE VALUE | WHETHER | |
|---|---|---|---|---|
| PER ASTMD3577-09 | OF SUBJECT | SUBJECT DEVICE | ||
| STANDARD | DEVICE | COMPLIED WITH | ||
| THE ASTMD3577 - | ||||
| 09 STANDARD | ||||
| 1 | Length ASTM D3577-09 | |||
| Size 5'/2 | Min 265mm | 282 mm | Yes | |
| Size 6 | Min 265mm | 282mm | Yes | |
| Size 6'/2 | Min 265mm | 282mm | Yes | |
| Size 7 | Min 265mm | 282mm | Yes |
SIZES AVAILABLE: - 5'/2, 6, 6'/2, 7, 7'/2, 8, 8'/2, 9
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| LENORA GLOVE PVT.LTD. | ||||
|---|---|---|---|---|
| SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'SGLOVE POWDER FREE | ||||
| Size 7'/2 | Min 265mm | 282mm | Yes | |
| Size 8 | Min 265mm | 282mm | Yes | |
| Size 8'/2 | Min 265mm | 282mm | Yes | |
| Size 9 | Min 265mm | 282mm | Yes | |
| 2 | Width ASTM D3577-09 | |||
| Size 5'/2 | 70+/-6mm | 71mm | Yes | |
| Size 6 | 76+/-6mm | 78mm | Yes | |
| Size 6'/2 | 83+/-6mm | 82mm | Yes | |
| Size 7 | 89+/-6mm | 90mm | Yes | |
| Size 7'/2 | 95+/-6mm | 95mm | Yes | |
| Size 8 | 102+/-6mm | 100mm | Yes | |
| Size 8'/2 | 108+/-6mm | 106mm | Yes | |
| Size 9 | 114+/-6mm | 112mm | Yes | |
| 3 | FingerThickness(All sizes) | Min 0.10mm | 0.20mm | Yes |
| 4 | Palm Thickness(All sizes) | Min 0.10mm | 0.16mm | Yes |
| 5 | Cuff Thickness(All sizes) | Min 0.10mm | 0.13mm | Yes |
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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVE POWDER FREE
| CRITERIA | SPECIFICATION ASPER ASTMD3577-09STANDARD | AVERAGEVALUE OFSUBJECTDEVICE | WHETHER SUBJECTDEVICE COMPLIEDWITH THEASTMD3577 -09STANDARD | |
|---|---|---|---|---|
| 6 | Tensile Strength ASTM D3577-09 | |||
| Before aging(All sizes) | 24Mpa minimum | 26.5Mpa | Yes | |
| After aging@70°±2C for166±2 hr(All sizes) | 18Mpa minimum | 21.0Mpa | Yes | |
| 7 | Ultimate Elongation ASTM D3577-09 | |||
| Before aging(All sizes) | 750% minimum | 860% | Yes | |
| After aging@70°±2C for166±2 hr(All sizes) | 560% minimum | 725% | Yes | |
| 8 | Stress at 500%before ageing(All sizes) | 5.5 MPa Max | 2.6 Mpa | Yes |
| 9 | Pinhole AQL ASTM D 5151-06(2015) | |||
| Before aging(All sizes) | Max 1.5 | 1.0 | Yes | |
| After aging@70°C for 7 days(All sizes) | Max 1.5 | 1.0 | Yes |
I. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).