(285 days)
Amazing+ Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Amazing Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free.
The provided text is a 510(k) Summary for a medical device: "Amazing+ Latex Examination Powder Free Gloves." This document describes the device and demonstrates its substantial equivalence to a legally marketed predicate device.
However, the request asks for information related to a study that proves a device meets acceptance criteria, specifically in the context of an AI-powered medical device (e.g., sample size for test set, data provenance, expert adjudication, MRMC study, standalone performance, ground truth establishment for training and test sets).
The provided 510(k) Summary does not describe an AI medical device. It describes physical specifications and performance of latex examination gloves. Therefore, many of the requested fields are not applicable to this type of device.
Despite this, I will extract and present the relevant information that is available in the document, and clearly state when information is not applicable to this physical device.
Device: Amazing+ Latex Examination Powder Free Gloves
K Number: K212597
Predicate Device: JR MEDIC Blue Latex Examination Powder Free Gloves (K192329)
1. A table of acceptance criteria and the reported device performance
| Characteristic | Standard/Test Method | Acceptance Criteria | Reported Device Performance | Comparison to Predicate |
|---|---|---|---|---|
| Dimensions - Length | ASTM D3578-2019 | Min 230 mm for all sizes | X-Small 305 mm, Small 306 mm, Medium 307 mm, Large 308 mm, X-Large 310 mm | Similar |
| Dimensions - Width | ASTM D3578-2019 | X-Small 70+/-10 mm, Small 80+/-10mm, Medium 95+/-10 mm, Large 111+/-10 mm, X-Large 115+/-10 mm | X-Small 76 mm, Small 85 mm, Medium 96 mm, Large 106 mm, X-Large 116 mm | Similar |
| Dimensions - Thickness | ASTM D3578-2019 | Palm > 0.08 mm min, Finger > 0.08 mm min for all sizes | Palm: 0.16mm (all sizes), Finger: 0.22mm (all sizes) | Similar |
| Physical Properties - Tensile Strength | ASTM D3578-2019 | Before Ageing: > 18 Mpa Min for all sizes. After Ageing: > 14 Mpa Min for all sizes. | Before Ageing: X-Small 22.07 Mpa, Small 22.15 Mpa, Medium 22.22 Mpa, Large 22.30 Mpa, X-Large 22.32 Mpa. After Ageing: X-Small 18.49 Mpa, Small 18.56 Mpa, Medium 18.67 Mpa, Large 18.74 Mpa, X-Large 18.76 Mpa. | Similar |
| Physical Properties - Ultimate Elongation | ASTM D3578-2019 | Before Ageing: > 650% Min for all sizes. After Ageing: > 500% Min for all sizes. | Before Ageing: X-Small 858%, Small 869%, Medium 874%, Large 880%, X-Large 882%. After Ageing: X-Small 841%, Small 848%, Medium 854%, Large 860%, X-Large 862%. | Similar |
| Physical Properties - Stress at 500% Elongation | ASTM D3578-2019 | Before Ageing: 5.5 Mpa Max for all sizes. | Before Ageing: X-Small 5.1 Mpa, Small 5.1 Mpa, Medium 5.2 Mpa, Large 5.2 Mpa, X-Large 5.2 Mpa. | N/A |
| Water Tightness (Holes) | ASTM D5151-2019 | AQL 2.5 | Gloves Pass AQL 1.5 | Same |
| Powder Free Residue | ASTM D6214 | <2 mg/glove Max | X-Small 0.21 mg/glove, Small 0.21 mg/glove, Medium 0.22 mg/glove, Large 0.22 mg/glove, X-Large 0.22 mg/glove | Similar |
| Biocompatibility - Primary Skin Irritation | ISO 10993-10:2010(E) | Under the condition of study, not an irritant | Under the condition of study, not an irritant | Same |
| Biocompatibility - Dermal Sensitization | ISO 10993-10:2010(E) | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer | Same |
| Biocompatibility - In vitro Cytotoxicity | ISO 10993-5:2009(E) | Under the conditions of the study, cytotoxic | Under the conditions of the study, cytotoxic (Note: This might seem counter-intuitive, but for certain test types, "cytotoxic" as a test result may simply indicate a reaction within the test conditions, not necessarily a failure from a biocompatibility standpoint for its intended use, especially if it's consistent with a cleared predicate. The key is that it's "Same" as the predicate's finding.) | Same |
| Biocompatibility - Material mediated Pyrogenicity | ISO 10993-11:2017(E) / USP 41<151> | Under the conditions of the study non pyrogenic | Under the conditions of the study, non-pyrogenic | Same |
| Biocompatibility - Acute Systemic Toxicity Test | ISO 10993-11:2017(E) | 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 | Same |
| Extractable Protein | ASTM D 5712-95 (Re approved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber | 200 µg/ dm² Max for all sizes | 43.65 µg/dm² (all sizes) | N/A (Not compared to predicate in table, but meets criteria) |
Information Not Applicable to this Device (as it's a physical product, not an AI/software device):
Given that the device is "Amazing+ Latex Examination Powder Free Gloves," the following sections of your request are not applicable as they pertain to AI/software functionality and clinical studies that are not performed for basic Class I examination gloves:
- 2. Sample size used for the test set and the data provenance: This device is a physical product. Testing involves laboratory measurements on physical samples (e.g., gloves from a production lot) to assess properties like dimensions, strength, and integrity, not dataset sizes. The provenance is from "Amazing Rubber Products Pvt. Ltd." in Cochin, Kerala, India. The tests are non-clinical, likely performed according to ISO/ASTM standards.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties is established by standardized measurement methods (e.g., ASTM standards), not expert opinion or consensus.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Physical measurements do not require 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 not an AI device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth for device performance is based on the specified ASTM and ISO standards for physical and chemical properties and biocompatibility testing.
- 8. The sample size for the training set: Not applicable. There is no "training set" for physical examination gloves; manufacturing process controls ensure consistent product.
- 9. How the ground truth for the training set was established: Not applicable. See above.
Summary of Non-Clinical Performance Data (Reiterated from document):
The performance test data of the non-clinical tests meet the following standards:
- ASTM D 3578-2019 Standard Specification for Rubber Examination Gloves
- ASTM D 5151-2019 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D 6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- ASTM D 5712-95 (Reapproved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber
Clinical Testing Summary:
- "This section is not applicable because clinical data not needed for gloves." (As stated in the document).
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May 28, 2022
Amazing Rubber Products Pvt Ltd % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE114 Aurora, Illinois 60504
Re: K212597
Trade/Device Name: Amazing+ Latex Examination Powder Free Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LYY Dated: May 2, 2022 Received: May 2, 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212597
Device Name
Amazing+ Latex Examination Powder Free Gloves
Indications for Use (Describe)
Amazing+ Latex Examination Powder Free Gloves are 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) | 区 Over-The-Counter Use (21 CFR 801 Subpart C) |
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510K SUMMARY
K212597
As required by 21CFR§807.92(c)
A. APPLICANT INFORMATION
| Applicant | Amazing Rubber Products Pvt. Ltd. |
|---|---|
| Address | Plot No 14c, Cochin Special Economic Zone , Kakkanad,Cochin-682 037, Kerala- India |
| Phone | 9447053062 |
| Fax | -------- |
| info@amazingglove.com | |
| Contact Person | Mr. Jayasankar S |
| Designation | Executive Director |
| Contact Number | 9447053062 |
| Contact Email | info@amazingglove.com |
| Date Submitted | 12 August 2021 |
B. DEVICE IDENTIFICATION
| Name of the device | Amazing+ Latex Examination Powder Free Gloves |
|---|---|
| Product proprietary or trade name | Amazing+ |
| Common or usual name | Latex Examination Powder Free Gloves |
| Classification name | Patient Examination Gloves |
| Device Classification | Class I |
| Product Code | LYY |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Legally Marketed devices thatEquivalency is claimed | JR MEDIC Blue Latex Examination Powder Free Gloves | |
|---|---|---|
| 510(K) Number | K192329 | |
| Regulatory Class | Class I | |
| Product code | LYY |
D. DESCRIPTION OF THE DEVICE:
Amazing Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free.
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E. INDICATIONS FOR USE/INTENDED USE OF THE DEVICE:
Amazing Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
Device Performance Characteristics Comparison Standards Predicate Current K192329 K212597 510(K) Number ---Name of device JR MEDIC Amazing ------Blue Latex Latex Examination Examination Powder Free Gloves Powder Free Gloves Dimensions-ASTM Length > 230 mm Length > 230 mm Length D3578-2019 Similar Size Average X-Small 305 Small 306 Medium 307 Large 308 X-Large 310 Dimensions- Width ASTM Width Min 95+/-Width Min 95+/-10 Similar D3578-2019 10 mm (for mm (for medium size) medium size) Size Average X-Small 76 Small 82 Medium 96 Large 106 X-Large 116 Physical Before Ageing ASTM Before Ageing Similar Properties-D3578-2019 Tensile Strength Tensile Strength > 18 Mpa Tensile > 18 Mpa Size Actual Strength value X-Small 22.07 Small 22.15 Medium 22.22 Large 22.30 X-Large 22.32 After Ageing After Ageing Similar Tensile Tensile Strength > 14 Mpa Strength Size Actual > 14 Mpa value X-Small 18.49 Small 18.56 Medium 18.67 18.74 Large X-Large 18.76
F. TECHNOLOGICAL CHARACTERISTICS
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| Characteristics | Standards | Device Performance | Comparison | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Predicate | Current | |||||||||||||||||||||
| 510(K) Number | K192329 | K212597 | ||||||||||||||||||||
| Physical Properties-Ultimate Elongation | ASTMD3578-2019 | Before AgeingUltimate Elongation > 650% | Before AgeingUltimate Elongation > 650%Size Actual value X-Small 858 Small 869 Medium 874 Large 880 X-Large 882 | Similar | ||||||||||||||||||
| After AgeingUltimate Elongation >500% | After AgeingUltimate Elongation > 500%Size Actual value X-Small 841 Small 848 Medium 854 Large 860 X-Large 862 | |||||||||||||||||||||
| Thickness | ASTMD3578-2019 | Palm > 0.08 mmFinger > 0.08 mm | Palm > 0.08 mmFinger > 0.08 mmSize Palm(Actual value) Finger(Actual value) X-Small 0.16 0.22 Small 0.16 0.22 Medium 0.16 0.22 Large 0.16 0.22 X-Large 0.16 0.22 | Similar | ||||||||||||||||||
| Powder Free Residue | ASTM D6214 | <2 mg/glove | <2 mg/glove Size Residualpowder content(mg/glove) X-Small 0.21 Small 0.21 Medium 0.22 Large 0.22 X-Large 0.22 | Similar | ||||||||||||||||||
| Biocompatibility | Primary SkinIrritation-ISO10993-10:2010(E) | Under the conditionof study, not anirritant | Under the condition of studynot an irritant | Same | ||||||||||||||||||
| DermalSensitization-ISO10993-10:2010(E) | Under the conditionsof the study, not asensitizer | Under the conditions of thestudy, not a sensitizer | Same | |||||||||||||||||||
| In vitrocytotoxicityISO10993-5:2009(E) | Under the conditionsof the study,cytotoxic | Under the conditions of thestudy, cytotoxic | Same | |||||||||||||||||||
| Material mediatedPyrogenicityISO 10993-11:2017(E) / USP41<151> | Under theconditions of thestudy non pyrogenic | Under the conditions of thestudy, non-pyrogenic | Same |
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| Characteristics | Standards | Device Performance | Comparison | |
|---|---|---|---|---|
| Predicate | Current | |||
| 510(K) Number | K192329 | K212597 | ||
| Biocompatibility | Acute SystemicToxicity Test ISO10993-11:2017(E) | Under the conditionsof study the deviceextracts do not pose asystemic toxicityconcern | Under the conditionsof study the device extractsdo not pose a systemictoxicity concern | same |
| Water Tight(1000 ml) | ASTM D5151-2019 | Passes AQL-1.5 | Passes AQL-1.5 | Same |
| Intended use | JR MEDIC Blue LatexExamination PowderFree Gloves aredisposable devicesintended for medicalpurpose that are wonon the examiner'shand to preventcontaminationbetween patient andexaminer. | Amazing LatexExamination Powder FreeGloves are disposabledevices intended for medicalpurpose that are worn on theexaminer's hand to preventcontamination betweenpatient and examiner. | Same | |
| Material | - | Natural Latex | Natural Latex | Identical |
| Color | - | Blue | Natural (No color is added) | different |
| Texture | - | Finger Texture | Finger texture | Identical |
| Size | ASTM D3578-2019 | Small, Medium, Large& X Large | X Small, Small,Medium, Large, X-Large | Similar |
| Single Use | Medical GloveGuidance Manual- Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non sterile | Non sterile | Same |
| Powder/Powderfree | - | Powder free | Powder free | Same |
| Label and Labeling | FDA Labelrequirements | Meets FDA's labeland labelingrequirements | Meets FDA's labeland labelingrequirements | Same |
| Manufacturer(s) | - | JR Engineering &Medical Technologies(M) SDN.BHD.Malaysia | Amazing Rubber ProductsPvt. Ltd. | --- |
G. SUMMARY OF NON-CLINICAL PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D3578-2019 StandardSpecification for Rubber ExaminationGloves | To determine thelength of the gloves | Min 230 mm for all sizes | X-Small 305 mmSmall 306 mmMedium 307 mmLarge 308 mmX-Large 310 mm |
| ASTM D3578-2019 StandardSpecification for Rubber ExaminationGloves | To determine the widthof the gloves | X-Small 70+/-10 mmSmall 80+/-10mmMedium 95+/-10 mmLarge 111+/-10 mmX-Large 115+/-10 mm | X-Small 76 mmSmall 85 mmMedium 96 mmLarge 106 mmX-Large 116 mm |
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| Test Method | Purpose | AcceptanceCriteria | Result | ||
|---|---|---|---|---|---|
| ASTM D3578-2019 StandardSpecification for RubberExamination Gloves | To determine the thickness ofthe gloves | Palm 0.08 mm minFinger 0.08 mm minfor all sizes | SizeX-SmallSmallMediumLargeX-Large | Palm0.16mm0.16mm0.16mm0.16mm0.16mm | Finger0.22mm0.22mm0.22mm0.22mm0.22mm |
| ASTM D3578-2019Standard Specification forRubber Examination Gloves | To Determine the physicalproperties-Tensile strength | Before AgeingTensile Strength18Mpa Min for allsizesAfter AgeingTensile Strength14Mpa Min for allsizes | SizeX-SmallSmallMediumLargeX-Large | Beforeageing22.07 Mpa22.15 Mpa22.22 Mpa22.30 Mpa22.32 Mpa | Afterageing18.49 Mpa18.56 Mpa18.67 Mpa18.74 Mpa18.76 Mpa |
| ASTM D3578-2019Standard Specification forRubber Examination Gloves | To Determine the physicalproperties-Ultimate Elongation | Before AgeingUltimate Elongation650% Min for allsizesAfter AgeingUltimate Elongation500% Min for allsizes | SizeX-SmallSmallMediumLargeX-Large | Beforeageing858%869%874%880%882% | Afterageing841%848%854%860%862% |
| To Determine the physicalproperties-stress at 500%Elongation | Before Ageing5.5 Mpa Max for allsizes | SizeX-SmallSmallMediumLargeX-Large | Beforeageing5.1 Mpa5.1 Mpa5.2 Mpa5.2 Mpa5.2 Mpa | NA | |
| ASTM D5151-2019 StandardTest Method for Detection ofHoles in Medical Gloves | To determine the holes in thegloves | AQL 2.5 | Gloves Passes AQL 1.5 | ||
| ASTM D6124-06(Reapproved 2017) StandardTest Method for ResidualPowder on Medical Gloves | To determine the residualpowder in the gloves | 2 Mg/Glove Max | SizeX-SmallSmallMediumLargeX-Large | Residual PowderContent0.21 mg/glove0.21 mg/glove0.22 mg/glove0.22 mg/glove0.22 mg/glove | |
| ASTM D 5712-95 (Reapproved 2010) Standard TestMethod for the Analysis ofProtein in Natural Rubber | To determine the extractableprotein in the gloves. | 200 µg/ dm² Max forall sizes | SizeX-SmallSmallMediumLargeX-Large | ExtractableProtein content43.65 µg/dm²43.65 µg/dm²43.65 µg/dm²43.65 µg/dm²43.65 µg/dm² |
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The performance test data of the non-clinical tests meet following standards:
- A ASTMD 3578-2019 Standard Specification for Rubber Examination Gloves
- ASTMD 5151-2019 Standard Test Method for Detection of Holes in Medical Gloves A
-
ASTMD 6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
-
ASTMD 5712-95 (Re approved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber
H. CLINICAL TESTING SUMMARY
This section is not applicable because clinical data not needed for gloves.
I. CONCLUSION
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission Amazing Latex Examination Powder Free Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device JR MEDIC Blue Latex Examination Powder Free Gloves (K192329).
§ 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.