(90 days)
APOLLO ADVANTAGE Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
APOLLO ADVANTAGE Nitrile Examination Gloves are made of Nitrile rubber and are blue in color. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151 and ASTM D6319. The proposed device is non-sterile and powder free.
This document is primarily concerned with the 510(k) premarket notification for APOLLO ADVANTAGE Nitrile Examination Gloves, asserting its substantial equivalence to a predicate device. It details acceptance criteria and performance data for various physical and biocompatibility characteristics of the gloves.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): | Length (mm): |
| S: ≥220 | S: 221-238mm | ||
| M/L/XL: ≥230 | M: 232-251mm; L: 232-243mm; XL: 234-250mm | ||
| Width (mm): | Width (mm): | ||
| S: 80 ± 10 | S: 80-89mm | ||
| M: 95 ± 10 | M: 94-104mm | ||
| L: 110 ± 10 | L: 102-111mm | ||
| XL: 120 ± 10 | XL: 111-122mm | ||
| Thickness (mm): | Thickness (mm): | ||
| Finger: ≥0.05 | Finger: S: 0.11-0.15mm; M: 0.11-0.15mm; L: 0.11-0.14mm; XL: 0.11-0.16mm | ||
| Palm: ≥0.05 | Palm: S: 0.08mm; M: 0.08mm; L: 0.08mm; XL: 0.08mm | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 (Acceptable Quality Limit) | 0 glove water leakage found |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 <2.0mg | 0.14-0.21mg |
| ASTM D6319 | Physical Properties (Before Aging) | Tensile Strength: ≥14Mpa | 34.1-39.0Mpa |
| Ultimate Elongation: ≥500% | 520.808%-637.854% | ||
| ASTM D6319 | Physical Properties (After Aging) | Tensile Strength: ≥14Mpa | 32.0-37.0Mpa |
| Ultimate Elongation: ≥500% | 463.000-562.586% | ||
| ISO 10993-11 | Biocompatibility: Acute Systemic Toxicity | Non-acute systemic toxicity under the conditions of the study. | The test article showed no evidence of causing acute system toxicity under the conditions of the study. |
| ISO 10993-10 | Biocompatibility: Skin Irritation | Non-irritating under the conditions of the study. | The test article has no skin irritation under the conditions of the study. |
| ISO 10993-10 | Biocompatibility: Dermal Sensitization | Non-sensitizing under the conditions of the study. | The test article showed no evidence of causing delayed dermal contact sensitization under the conditions of the study. |
2. Sample size used for the test set and the data provenance:
The document doesn't explicitly state specific sample sizes for each test. Instead, it refers to compliance with established ASTM and ISO standards for medical devices and biocompatibility. These standards typically define acceptable sampling plans. The data provenance is not explicitly mentioned, but given the manufacturer (Dell Corning Corporation) with an address in South Carolina, USA, and an Asia Co., Ltd in Wuhan, China, and the nature of the tests, it's likely conducted in a controlled laboratory setting by or for the manufacturer. The tests are non-clinical (laboratory-based) rather than retrospective or prospective patient studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in a way that is applicable to human expert review. For these types of device performance tests (physical properties, watertightness, powder content, biocompatibility), the "ground truth" is established by the specifications and methodologies outlined in the referenced international standards (ASTM and ISO). The testing would be performed by qualified laboratory personnel following these validated procedures, not typically by human experts reviewing results for subjective interpretation.
4. Adjudication method for the test set:
Not applicable in the context of this type of device testing. The results are quantitative measurements against objective criteria defined by the standards. There is no subjective interpretation requiring adjudication among experts.
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 medical device clearance for examination gloves, not an AI-assisted diagnostic or imaging device. There are no "human readers" or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device (examination gloves), not an algorithm or software.
7. The type of ground truth used:
The ground truth for these tests is based on established international and national standards and specifications:
- ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-10 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)
- ISO 10993-11 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)
The device's performance is compared against the quantified acceptance criteria outlined in these standards.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
June 5, 2023
Dell Corning Corporation % Yiren Qiao General Manager Dell Corning Asia Co., Ltd 12E, 7th Floor, Bank of China Tower, Qingshan District Wuhan, Hubei 430000 China
Re: K230633
Trade/Device Name: APOLLO ADVANTAGE Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: March 3, 2023 Received: March 7, 2023
Dear Yiren Qiao:
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 -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
APOLLO ADVANTAGE Nitrile Examination Gloves
Indications for Use (Describe)
APOLLO ADVANTAGE Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands 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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Image /page/3/Picture/0 description: The image contains the logo for Dow Corning Corporation. The logo features the words "Dow" and "Corning" stacked on top of each other in a bold, sans-serif font. The word "Dow" is in a lighter gray color, while "Corning" is in a darker blue color. Below the two words is the word "corporation" in a smaller, lighter font.
510(k) Summary
K230633
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
5.1 Submitter
| Submitted by: | Dell Corning Corporation |
|---|---|
| Address: | 575 John Dodd Road, Spartanburg, South Carolina 29303, USA. |
| Contact Person: | Yiren QiaoGeneral Manager |
| Dell Corning Asia Co., Ltd | |
| Address: | 12E, 7th Floor, Bank of China Tower, Qingshan District,Wuhan, Hubei 430000China |
| Phone: | +86-15871756987 |
| Email: | kinginsky@126.com |
| Date Prepared: | May 18, 2023 |
5.2 Device
| Device Name: | APOLLO ADVANTAGE Nitrile Examination Glove |
|---|---|
| Classification Name: | Polymer Patient Examination Glove |
| Regulatory Class: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Regulation Name: | Non-powdered patient examination glove |
| Product Code: | LZA |
| Size: | S, M, L, XL |
5.3 Predicate Device
| Device Name: | Nitrile Examination Glove, K213739 | ||
|---|---|---|---|
| Manufacturer: | Hangzhou Runheng Medical Co., Ltd | ||
| Classification Name: | Polymer Patient Examination Glove | ||
| Regulatory Class: | I | ||
| Regulation Number: | 21 CFR 880.6250 | ||
| Regulation Name: | Non-powdered patient examination glove | ||
| Product Code: | LZA | ||
| Size: | XS, S, M, L, XL |
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Image /page/4/Picture/0 description: The image shows the logo for Dell Corning Corporation. The word "Dell" is in a gray, italicized font and is stacked on top of the word "Corning" which is in a bold, blue font. Below the two words is the word "corporation" in a smaller, blue font.
5.4 Device Description
APOLLO ADVANTAGE Nitrile Examination Gloves are made of Nitrile rubber and are blue in color. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151 and ASTM D6319. The proposed device is non-sterile and powder free.
5.5 Indication for Use:
APOLLO ADVANTAGE Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
| Table 5-1 General Comparison | |||
|---|---|---|---|
| Item | Proposed Device | Predicate | Remark |
| APOLLOADVANTAGE NitrileExamination Gloves | Device(K213739)Nitrile ExaminationGlove | ||
| Product Code | LZA | LZA | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Classification | I | I | Same |
| Indication for Use | APOLLOADVANTAGE NitrileExamination Gloves aredisposable devicesintended for medicalpurposes that are wornon the examiner's handsto preventcontamination betweenpatient and examiner. | Nitrile ExaminationGloves are disposabledevices intended formedical purpose thatare worn on theexaminer's hand toprevent contaminationbetween patient andexaminer. | Same |
| Material | Nitrile | Nitrile | Same |
| Powered or PoweredFree | Powered Free | Powered Free | Same |
| Color | Blue | Blue | Same |
5.6 Comparison of Technological Characteristics
| Proposed Device | Standard | Designation | Size | Tolerance | |||
|---|---|---|---|---|---|---|---|
| APOLLOADVANTAGENitrileExaminationGloves | ASTMD6319 | Length,mm | S | M | L | XL | min |
| Width, mm | 80 | 95 | 110 | 120 | ±10 | ||
| Thickness,mm | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min |
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Image /page/5/Picture/0 description: The image shows the logo for Dell Corning Corporation. The word "Dell" is in a light gray color and is stacked on top of the word "Corning" which is in black. Below the word "Corning" is the word "Corporation" which is in a light blue color.
| Predicate | Standard | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|---|
| Device(K213739)NitrileExaminationGloveASTM D6319 | ASTMD6319 | Length,mm | XS* | S | M | L | XL | min |
| Width,mm | 70 | 80 | 95 | 110 | 120 | ±10 | ||
| Thickness, mm | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| Remark | Similar*Difference discussion: No size XS is included in oursubmission. But all sizes we submitted met the specification ofASMT D6319. |
- Table 5-3 Performance Comparison
| Item | APOLLOADVANTAGENitrile ExaminationGloves(Proposed Device) | Nitrile ExaminationGlove(PredicateDevice, K213739) | Remark | ||
|---|---|---|---|---|---|
| Colorant | Blue | Blue | Same | ||
| PhysicalProperties | BeforeAgingComplywithASTMD6319 | TensileStrength | 14MPa,min | 14MPa,min | Same |
| ComplywithASTMD6319 | UltimateElongation | 500%min | 500%min | Same | |
| AfterAgingComplywithASTMD6319 | TensileStrength | 14Mpa, min | 14Mpa, min | Same | |
| ComplywithASTMD6319 | UltimateElongation | 400% min | 400% min | Same | |
| Freedom from Holes | Free from holes whentested in accordancewith ASTM D5151AQL=2.5 | Free from holeswhen tested inaccordance withASTM D5151AQL=2.5 | Same | ||
| Powder Content | 0.14mg-0.21mg | <2mg/glove | Similar |
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| Table 5-4 Biocompatibility Testing Comparison | ||||
|---|---|---|---|---|
| Item | APOLLOADVANTAGENitrile ExaminationGloves(Proposed Device) | Nitrile ExaminationGlove (PredicateDevice, K213739) | Remark | |
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | IrritationISO 10993-10:2010 | The testarticle has no skinirritation under theconditions of thestudy. | Not an irritant underthe conditions of thestudy | Same |
| SensitizationISO 10993-10:2010 | The test articleshowed no evidenceof causing delayeddermal contactsensitization underthe conditions of thestudy. | Not a sensitizerunder the conditionsof the study | Same | |
| SystemictoxicityISO 10993-11:2017 | The test articleshowed no evidenceof causing acutesystem toxicityunder the conditionsof the study. | Device extracts donot pose a systemictoxicity concernunder the conditionsof the study. | Same | |
Table 5-4 Biocompatibility Testing Comparison
5.7 Non-clinical Performance Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity. ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves.
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length(mm):S:≥220;M/L/XL:≥230; | Length(mm):S:221-238mm;M:232-251mm;L:232-243mm; |
Table 5-5 Summary of non-clinical performance testing
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Image /page/7/Picture/1 description: The image shows the logo for Dow Corning Corporation. The word "Dow" is in a light gray color and is stacked on top of the word "Corning" which is in a dark blue color. Below the word "Corning" is the word "corporation" in a smaller font and a light blue color.
| Width(mm): | XL:234-250mm; | ||||
|---|---|---|---|---|---|
| S:80±10; | |||||
| M:95±10; | Width(mm): | ||||
| L:110±10; | S:80-89mm; | ||||
| XL:120±10 | M:94-104mm; | ||||
| L:102-111mm;; | |||||
| XL:111-122mm; | |||||
| Thickness(mm): | Thickness(mm): | ||||
| Finger:≥0.05 | Finger: | ||||
| Palm:≥0.05 | S:0.11-0.15mm | ||||
| M:0.11-0.15mm | |||||
| L:0.11-0.14mm | |||||
| XL:0.11-0.16mm | |||||
| Palm: | |||||
| Finger:0.08mm | |||||
| S:0.08mm | |||||
| M:0.08mm | |||||
| L:0.08mm | |||||
| XL:0.08mm | |||||
| ASTM D5151 | Watertightness Test forDetection of Holes | Meet the requirements ofASTM D5151 AQL 2.5 | 0 glove water leakagefound | ||
| ASTM D6124 | Powder Content | Meet the requirements ofASTM D6124 <2.0mg | 0.14-0.21mg | ||
| ASTM D6319 | Physical Properties | BeforeAging | TensileStrength | ≥14Mpa | 34.1-39.0Mpa |
| UltimateElongation | ≥500% | 520.808%-637.854% | |||
| AfterAging | TensileStrength | ≥14Mpa | 32.0-37.0Mpa | ||
| UltimateElongation | ≥500% | 463.000-562.586% | |||
| ISO 10993-11 | Biocompatibility:Acute SystemicToxicity | Non-acute systemic toxicityunder the conditions of the study. | The test article showedno evidence of causingacute system toxicityunder the conditions ofthe study. | ||
| ISO 10993-10 | Biocompatibility:Skin Irritation | Non-irritating under theconditions of the study. | The test article has noskin irritation under theconditions of the study. | ||
| ISO 10993-10 | Biocompatibility:Dermal Sensitization | Non-sensitizing under theconditions of the study. | The test article showedno evidence of causingdelayed dermal contactsensitization under theconditions of the study. |
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Image /page/8/Picture/0 description: The image shows the logo for Dell Corning Corporation. The word "Dell" is written in a stylized font in a light gray color. Below "Dell" is the word "Corning" in a bold, dark blue font. Underneath "Corning" is the word "corporation" in a smaller, regular font, also in dark blue.
| conditions of the study. | |||
|---|---|---|---|
| -- | -- | -- | -------------------------- |
5.8 Clinical Test Data
Not Applicable
5.9 Conclusion
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicated device Nitrile Examination Glove by Hangzhou Runheng Medical Co., Ltd, cleared under 510(k) K213739.
§ 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.