(90 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML.
No
The device, APOLLO ADVANTAGE Nitrile Examination Gloves, is intended to prevent contamination between patient and examiner and does not perform any therapeutic function.
No
Explanation: The provided text clearly states that the device is "Nitrile Examination Gloves," which are intended to be worn on the hands to prevent contamination. There is no mention of the device being used to diagnose any medical condition, analyze data, or produce diagnostic information.
No
The device is a physical product (nitrile gloves) and not software. The description focuses on material properties and physical performance tests.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to diagnose, monitor, or screen for diseases.
- Intended Use: The intended use of the APOLLO ADVANTAGE Nitrile Examination Gloves is "to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: The description focuses on the physical properties and standards related to a protective glove, not a diagnostic assay or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The device is clearly described as a medical device intended for barrier protection during medical examinations.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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: ASTM D6319; Purpose: Physical Dimensions Test; Acceptance Criteria: Length(mm): S:>=220; M/L/XL:>=230; Width(mm): S:80+/-10; M:95+/-10; L:110+/-10; XL:120+/-10 Thickness(mm): Finger:>=0.05 Palm:>=0.05; Results: Length(mm): S:221-238mm; M:232-251mm; L:232-243mm; XL:234-250mm; Width(mm): S:80-89mm; M:94-104mm; L:102-111mm; XL:111-122mm; Thickness(mm): Finger: 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
Test Method: ASTM D5151; Purpose: Watertightness Test for Detection of Holes; Acceptance Criteria: Meet the requirements of ASTM D5151 AQL 2.5; Results: 0 glove water leakage found
Test Method: ASTM D6124; Purpose: Powder Content; Acceptance Criteria: Meet the requirements of ASTM D6124 =14Mpa; Ultimate Elongation >=500%; After Aging Tensile Strength >=14Mpa; Ultimate Elongation >=500%; Results: Before Aging 34.1-39.0Mpa; 520.808%-637.854%; After Aging 32.0-37.0Mpa; 463.000-562.586%
Test Method: ISO 10993-11; Purpose: Biocompatibility: Acute Systemic Toxicity; Acceptance Criteria: Non-acute systemic toxicity under the conditions of the study.; Results: The test article showed no evidence of causing acute system toxicity under the conditions of the study.
Test Method: ISO 10993-10; Purpose: Biocompatibility: Skin Irritation; Acceptance Criteria: Non-irritating under the conditions of the study.; Results: The test article has no skin irritation under the conditions of the study.
Test Method: ISO 10993-10; Purpose: Biocompatibility: Dermal Sensitization; Acceptance Criteria: Non-sensitizing under the conditions of the study.; Results: The test article showed no evidence of causing delayed dermal contact sensitization under the conditions of the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
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 -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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 Qiao |
| General Manager | |
| Dell Corning Asia Co., Ltd | |
| Address: | 12E, 7th Floor, Bank of China Tower, Qingshan District, |
| Wuhan, Hubei 430000 | |
| China | |
| 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 |
| APOLLO | |||
| ADVANTAGE Nitrile | |||
| Examination Gloves | Device(K213739) | ||
| Nitrile Examination | |||
| Glove | |||
| Product Code | LZA | LZA | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Classification | I | I | Same |
| 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. | Nitrile Examination | ||
| Gloves are disposable | |||
| devices intended for | |||
| medical purpose that | |||
| are worn on the | |||
| examiner's hand to | |||
| prevent contamination | |||
| between patient and | |||
| examiner. | Same | ||
| Material | Nitrile | Nitrile | Same |
| Powered or Powered | |||
| Free | Powered Free | Powered Free | Same |
| Color | Blue | Blue | Same |
5.6 Comparison of Technological Characteristics
| Proposed Device | Standard | Designation | Size | Tolerance | |||
|---|---|---|---|---|---|---|---|
| APOLLO | |||||||
| ADVANTAGE | |||||||
| Nitrile | |||||||
| Examination | |||||||
| Gloves | ASTM | ||||||
| D6319 | 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) | ||||||||
| Nitrile | ||||||||
| Examination | ||||||||
| Glove | ||||||||
| ASTM D6319 | ASTM | |||||||
| D6319 | 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 our | ||||||||
| submission. But all sizes we submitted met the specification of | ||||||||
| ASMT D6319. |
- Table 5-3 Performance Comparison
| | Item | | APOLLO
ADVANTAGE
Nitrile Examination
Gloves
(Proposed Device) | Nitrile Examination
Glove(Predicate
Device, K213739) | Remark |
|------------------------|----------------------------------------------------|------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------|
| Colorant | | | Blue | Blue | Same |
| Physical
Properties | Before
Aging
Comply
with
ASTM
D6319 | Tensile
Strength | 14MPa,min | 14MPa,min | Same |
| | Comply
with
ASTM
D6319 | Ultimate
Elongation | 500%min | 500%min | Same |
| | After
Aging
Comply
with
ASTM
D6319 | Tensile
Strength | 14Mpa, min | 14Mpa, min | Same |
| | Comply
with
ASTM
D6319 | Ultimate
Elongation | 400% min | 400% min | Same |
| Freedom from Holes | | | Free from holes when
tested in accordance
with ASTM D5151
AQL=2.5 | Free from holes
when tested in
accordance with
ASTM D5151
AQL=2.5 | Same |
| Powder Content | | | 0.14mg-0.21mg |