(120 days)
Clover Glove Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Clover Glove Nitrile Examination Gloves Powder Free is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319 -19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous and are powder free. The product is non-sterile.
The acceptance criteria and performance of the Clover Glove Nitrile Examination Gloves Powder Free are described below based on the provided FDA 510(k) summary.
1. A table of acceptance criteria and the reported device performance
| Test Category | Characteristic/Test | Acceptance Criteria (ASTM D6319-19 unless specified) | Reported Device Performance (Clover Glove) | Result |
|---|---|---|---|---|
| Dimensions | Length | 230mm Min | S: 245.15mm, M: 247.1mm, L: 248.30mm | Pass |
| Width (for Medium size) | 95mm ±10 | M: 92.69 mm (within 95±10) | Pass | |
| Width (for Small size) | 80mm ±10 | S: 83mm (within 80±10) | Pass | |
| Width (for Large size) | 110mm ±10 | L: 108.07mm (within 110±10) | Pass | |
| Thickness (Palm) | S: 0.05 mm Min, M: 0.05 mm Min, L: 0.05 mm Min | S: 0.08 mm, M: 0.09 mm, L: 0.09 mm | Pass | |
| Thickness (Finger) | S: 0.05 mm Min, M: 0.05 mm Min, L: 0.05 mm Min | S: 0.123mm, M: 0.138mm, L: 0.14mm | Pass | |
| Physical Property | Tensile Strength (Before Aging) | 14 MPa Min | S: 30.60 MPa, M: 31.72 MPa, L: 37.01 MPa | Pass |
| Tensile Strength (After Aging) | 14 MPa Min | S: 30.66 MPa, M: 30.80 MPa, L: 35.46 MPa | Pass | |
| Ultimate Elongation (Before Aging) | 500% Min | S: 604.61%, M: 575.38%, L: 596.92% | Pass | |
| Ultimate Elongation (After Aging) | 400% Min | S: 573.84%, M: 580%, L: 566.15% | Pass | |
| Barrier Property | Detection of Holes (AQL) (ASTM D6319-19, ASTM D5151-19) | AQL 2.5 for all sizes | AQL 2.5 for all sizes | Pass |
| Powder Residue | Powder Free Residue (ASTM D6124-06) | ≤2 mg/glove Max | S: 0.42mg, M: 0.34mg, L: 0.20mg | Pass |
| Biocompatibility | In Vitro Cytotoxicity (ISO 10993-1:2018) | Under the conditions of the study, non-cytotoxic. | Under the conditions of the study, cytotoxic. * | Different |
| Skin Sensitization (ISO 10993-1:2018) | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer | Pass | |
| Skin Irritation (ISO 10993-1:2018) | Under the condition of study not an irritant | Under the condition of study not an irritant | Pass | |
| Acute Systemic Toxicity (ISO 10993-1:2018) | Device extracts do not pose a systemic toxicity concern. | Device extracts do not pose a systemic toxicity concern. | Pass | |
| Material Mediated Pyrogenicity (ISO 10993-1:2018) | Device did not demonstrate a material mediated pyrogenicity response. | Device did not demonstrate a material mediated pyrogenicity response. | Pass |
*Note on Cytotoxicity: The device initially showed a cytotoxic response, but additional testing for acute systemic toxicity concluded that the observed cytotoxicity was not a significant clinical concern, as it did not induce systemic toxicity in test animals.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each of the performance or biocompatibility tests. It refers to "actual data" for the device, implying that testing was conducted on samples of the Clover Glove.
The provenance of the data is that it was generated for the purpose of this 510(k) submission, likely by Clover Glove Company Limited or a contracted testing facility. The specific country of origin for the testing is not stated, but the company itself is located in Thailand. The testing appears to be prospective as it's specifically conducted for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device is a medical glove. The 'ground truth' is established by adherence to recognized international standards (ASTM) and biocompatibility testing according to ISO 10993-1, rather than expert consensus on medical images or diagnoses.
4. Adjudication method for the test set
This information is not applicable as the device is a medical glove. The performance is assessed against predefined quantitative and qualitative criteria from established standards, not through adjudication of expert opinions.
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
This information is not applicable as the device is a medical glove and not an AI-assisted diagnostic or imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a medical glove and not an algorithm or AI system.
7. The type of ground truth used
The ground truth for the performance tests (dimensions, physical properties, barrier properties, powder residue) is based on established standard specifications, specifically ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves), and ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves).
For biocompatibility, the ground truth is established by adherence to internationally recognized standards for biological evaluation of medical devices, specifically ISO 10993-1:2018 (Biological Evaluation of Medical Devices - Part 1, Evaluation and Testing within a Risk Management Process).
8. The sample size for the training set
This information is not applicable as the device is a physical medical product (gloves) and not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
March 26, 2022
Clover Glove Company Limited % Manoj Zacharias US Agent Liberty Management Group Limited 75 Executive Drive, Suite 114 Aurora, Illinois 60504
Re: K213729
Trade/Device Name: Clover Glove Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: March 02, 2022 Received: March 07, 2022
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.
{1}------------------------------------------------
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian, M.D., Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K213729
Device Name
Clover Glove Nitrile Examination Gloves Powder Free
Indications for Use (Describe)
Clover Glove Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Clover Glove. The logo consists of a four-leaf clover on the left, with the top two leaves being green and the bottom left leaf being red. The bottom right leaf is also green. To the right of the clover is the word "CLOVER" in gray, with the "V" in red. Below the word "CLOVER" is a horizontal line, and below that is the word "GLOVE" in gray, with the "G" in orange.
510(k) SUMMARY (K213729)
[AS REQUIRED BY 21CFR807.92]
I. SUBMITTER
| 510(k) Owner's Name | Clover Glove Company Limited |
|---|---|
| Address | 1999/8 District Sriwara Village, Ladphrao 94 (Punjamit),Sriwara Rd, Plabphla, Wang Thong Lang, Krung Thep MahaNakhon, Thailand 10240 |
| Telephone | +66 64 92 44991 |
| Contact person | Mr.Pongsin Pongwachirint |
| Designation | Managing Director |
| Contact Email | pongsin.p@cloverglove.co.th |
| Date of Summary Prepared | 25.03.2022 |
II. DEVICE
| Device Trade Name | Clover Glove |
|---|---|
| Device Common Name | Nitrile Examination Gloves Powder Free |
| Device Classification name | Non-powdered patient examination glove |
| Regulation Number | 21 CFR 880.6250 |
| Class | I |
| Product Code | LZA |
III. PREDICATE DEVICE
| Predicate Device Name | Jr Medic Blue Nitrile Examination Gloves Powder Free |
|---|---|
| 510(k) Number | K192333 |
| Regulation Number | 21 CFR 880.6250 |
| Class | I |
| Product Code | LZA |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Clover Glove. The logo consists of a four-leaf clover on the left, with the top two leaves being green and the bottom left leaf being red. The bottom right leaf is also green. To the right of the clover is the word "CLOVER" in gray letters, except for the "V" which is red. Below the word "CLOVER" is a green line, and below that is the word "GLOVE" in gray letters, except for the "G" which is orange.
IV. DEVICE DESCRIPTION
Clover Glove Nitrile Examination Gloves Powder Free is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319 -19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous and are powder free. The product is non-sterile.
V. INDICATIONS OF USE
Clover Glove Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| SI.No | Features compared | Proposed Device | Predicate Device | Result | |
|---|---|---|---|---|---|
| General Information | |||||
| 1. | 510(k) Number | K213729 | K192333 | - | |
| 2. | Manufacturer | Clover Glove Company Limited | JR Engineering & MedicalTechnologies (M) SDN.BHD | - | |
| 3. | Classification | I | I | Same | |
| 4. | Regulation number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | |
| 5. | Product Code | LZA | LZA | Same | |
| 6. | Indication For Use | Clover Glove Nitrile ExaminationGloves Powder Free is a disposabledevice intended for medicalpurpose that is worn on theexaminer's hand to preventcontamination between patientand examiner. | Jr Medic Blue Nitrile ExaminationGloves Powder Free are intendedfor medical purposes that is wornon the examiner's hands toprevent contamination betweenpatient and examiner. | Same | |
| 7. | Material | Nitrile | Nitrile | Same | |
| 8. | Color | Blue | Blue | Same | |
| 9. | Texture | Finger Texture | Finger texture | Same | |
| 10. | Ambidextrous | Yes | Data not available | - | |
| 11. | Size | S, M, L | XS, S, M, L, XL | Similar | |
| 12. | OTC Use | Yes | Yes | Same | |
| SI.No | Features compared | Proposed Device | Predicate Device | Result | |
| 13. | Reusability | Single use | Single use | Same | |
| 14. | Sterility | Non- sterile | Non- sterile | Same | |
| 15. | Dimensions | Length Min 230 mmWidth Min 95±10Mm (for medium size) | Length Min 230 mmWidth Min 95±10Mm (for medium size) | Same | |
| 16. | Thickness | Palm min 0.05 mmFinger min 0.05 mm | Palm min 0.05 mmFinger min 0.05 mm | Same | |
| 17. | Physical Properties | Before AgingTensile Strength min 14 MPaUltimate Elongation Min 500%After AgingTensile Strength min 14 MPaUltimate Elongation Min 400% | Before AgingTensile Strength min 14 MPaUltimate Elongation Min 500%After AgingTensile Strength min 14 MPaUltimate Elongation Min 400% | Same | |
| 18. | Detection of Holes | Passes AQL 2.5 | Passes AQL 1.5 | Similar | |
| 19. | Powder Free Residue | ≤2 mg/glove Max | ≤2 mg/glove Max | Same | |
| 20. | Shelf Life | 3 Years | Data Not Available | - | |
| 21. | Biocompatibility Study | In Vitro Cytotoxicity | Under the conditions of the study,cytotoxic. Additional testing wasperformed to determine if this wasa systemic toxicity concern. | Under the conditions of the study,cytotoxic. Additional testing wasperformed to determine if thiswas a systemic toxicity concern. | Same |
| Skin Sensitization | Under the condition of the studynot a sensitizer | Under the condition of the studynot a sensitizer | Same | ||
| Skin Irritation | Under the condition of the studynot an irritant | Under the condition of the studynot an irritant | Same | ||
| Acute SystemicToxicity | Under the conditions of study, thedevice extracts do not pose asystemic toxicity concern | Under the conditions of study, thedevice extracts do not pose asystemic toxicity concern | Same | ||
| Material MediatedPyrogenicity | Under the conditions of the study, thedevice did not demonstrate amaterial mediated pyrogenicityresponse. | Under the conditions of thestudy, the device did notdemonstrate a material mediatedpyrogenicity response. | Same |
Table 1: General Comparison
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Clover Glove. The logo consists of a four-leaf clover on the left and the words "CLOVER GLOVE" on the right. The clover has two green leaves, one red leaf, and one yellow leaf. The words "CLOVER GLOVE" are in gray, with the "V" in "CLOVER" being red and the "G" in "GLOVE" being yellow. A green line separates the two words.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image is a logo for Clover Glove. The logo consists of a four-leaf clover on the left and the words "CLOVER GLOVE" on the right. The clover is made up of four circles, with the top left circle being red, the top right and bottom left circles being green, and the bottom right circle being orange. The word "CLOVER" is in gray, except for the letter "V", which is red. The word "GLOVE" is in gray, except for the letter "G", which is orange.
PERFORMANCE DATA VII.
A. Non- Clinical Data
Performance Tests
Clover Glove Nitrile Examination Gloves Powder Free is subjected to the following performance tests according to the requirements of Guidance for Industry and FDA Staff - Medical Glove Guidance Manual and found to be safe and efficient with respect to its intended use:
- Dimension
- Physical property
- Barrier property tests
- Δ Detection of Holes in Medical Gloves
- Powder Free Residue
| SINo. | Tests | Proposed DeviceActual Data | Acceptance Criteria | Result | ||||
|---|---|---|---|---|---|---|---|---|
| 1. | Size | Length | Width | Size | Length | Width | ||
| DimensionLength, Width andThickness | S | 245.15mm | 83mm | S | 80mm±10 | Pass | ||
| M | 247.1 mm | 92.69 mm | M | 230mm Min | 95mm ±10 | |||
| L | 248.30mm | 108.07mm | L | 110mm ±10 | ||||
| ASTM D6319-19 | Thickness | Thickness | ||||||
| Standard Specification forNitrile Examination Glovesfor Medical Application | Size | Palm | Finger | Size | Palm | Finger | ||
| S | 0.08 mm | 0.123mm | S | 0.05 mm | 0.05 mm | Pass | ||
| M | 0.09 mm | 0.138mm | M | Min | Min | |||
| L | 0.09 mm | 0.14mm | L | |||||
| 2. | Tensile strength | Tensile strength | ||||||
| Physical propertyTensile strength andUltimate Elongation | Size | BeforeAging | AfterAging | Size | BeforeAging | AfterAging | ||
| S | 30.60 MPa | 30.66 MPa | S | 14 MPa | 14 MPa | Pass | ||
| M | 31.72 MPa | 30.80 MPa | M | Min | Min | |||
| L | 37.01 MPa | 35.46 MPa | L | |||||
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application | Ultimate Elongation | Ultimate Elongation | ||||||
| Size | BeforeAging | AfterAging | Size | BeforeAging | AfterAging | |||
| S | 604.61% | 573.84% | S | 500% | 400% | |||
| M | 575.38% | 580% | M | Min | Min | |||
| L | 596.92% | 566.15% | L |
Table 2: Performance Testing Summary
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Clover Glove. The logo has a four-leaf clover on the left side, with the top two leaves being green and the bottom left leaf being red and the bottom right leaf being green. To the right of the clover is the word "CLOVER" in gray, with the "V" in red. Below the word "CLOVER" is a green line, and below that is the word "GLOVE" in gray, with the "G" in orange.
| SINo. | Tests | Proposed DeviceActual Data | Acceptance Criteria | Result | ||
|---|---|---|---|---|---|---|
| 3. | Barrier property testsDetection of Holes inMedical GlovesASTM D6319-19ASTM D5151-19Standard Test Method forDetection of Holes in MedicalGloves | AQL 2.5 for all sizes | AQL 2.5 for all sizes | Pass | ||
| 4. | Powder Free Residue | Size | Residual powder content | Size | Residual powder content | |
| ASTM D6124-06(Reapproved 2017) | S | 0.42mg | S | Pass | ||
| Standard Test Method for | M | 0.34mg | M | ≤2Mg/ Glove Max | ||
| Residual Powder on MedicalGloves | L | 0.20mg | L |
Biocompatibility B.
The materials used in the Clover Glove Nitrile Examination Gloves Powder Free are biocompatible based on the biocompatibility tests mentioned in the Guidance for Industry and FDA Staff - Medical Glove Guidance Manual:
- In Vitro Cytotoxicity
- Skin Sensitization
- Skin Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
These tests were performed according to ISO 10993-1:2018, Biological Evaluation of Medical Devices -Part 1, Evaluation and Testing within a Risk Management Process.
| Table 3: Biocompatibility Test Summary | ||
|---|---|---|
| -- | ---------------------------------------- | -- |
| SI.No | Test Performed | Proposed Device | Acceptance Criteria | Result |
|---|---|---|---|---|
| 1. | In Vitro Cytotoxicity | Under the conditions of the study,cytotoxic.Additionaltestingwasperformed to determine if this was asystemic toxicity concern. | Under the conditions of thestudy, non-cytotoxic. | Different |
| 2. | Skin Sensitization | Under the conditions of the study nota sensitizer | Under the conditions of thestudy not a sensitizer | Pass |
| 3. | Skin Irritation | Under the condition of study not anirritant | Under the condition of studynot an irritant | Pass |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Clover Glove. The logo has a four-leaf clover on the left side, with the top two leaves being green and the bottom left leaf being red. The bottom right leaf is also green. To the right of the clover is the word "CLOVER" in gray letters, except for the "V" which is red. Below the word "CLOVER" is a green line, and below that is the word "GLOVE" in gray letters, except for the "G" which is yellow.
| 4. | Acute Systemic Toxicity | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Pass |
|---|---|---|---|---|
| 5. | MaterialMediatedPyrogenicity | Under the condition of the study, The device did not demonstrate a Material mediated pyrogenicity response | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. | Pass |
-
- Since the cytotoxic study showing positive cytotoxic response, additional testing for acute systemic toxicity is conducted to determine if this was a systemic toxicity concern and it showed that the subject glove did not induce systemic toxicity in the test animals, which demonstrated that the cytotoxicity reactivity observed is not a significant concern in clinical settings.
C. Clinical Test Data
Clinical study was not conducted as clinical data is not needed for Clover Glove Nitrile Examination Gloves Powder Free.
VIII. CONCLUSION
The conclusion drawn from the non-clinical tests demonstrate that the subject device in 510(k) submission, Clover Glove Nitrile Examination Gloves Powder free is as effective, and performs as well as or better than the legally marketed predicate device, 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.