(285 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of examination gloves, with no mention of AI or ML technology.
No
The device, Amazing+ Latex Examination Powder Free Gloves, is intended to prevent contamination and is described as a medical device for examination, not for treating or diagnosing a disease or condition.
No
The device, Amazing+ Latex Examination Powder Free Gloves, is described as a disposable device worn on the examiner's hand to prevent contamination. Its function is protective, not diagnostic.
No
The device is a physical product (gloves) and the description focuses on material properties and performance testing related to those physical properties, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for infection control, not a device used to examine specimens from the human body to provide diagnostic information.
- Device Description: The description focuses on the physical and chemical properties of the gloves (material, color, powder-free, meeting ASTM standards). This aligns with a medical device for protection, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic results. The performance studies focus on the physical integrity and biocompatibility of the gloves, not diagnostic accuracy.
Therefore, the Amazing+ Latex Examination Powder Free Gloves are classified as a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LYY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purpose)
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 performance data was submitted based on the following test methods and standards:
- ASTM D3578-2019 Standard Specification for Rubber Examination Gloves for determinations of length, width, thickness, physical properties (tensile strength, ultimate elongation, stress at 500% elongation).
- ASTM D5151-2019 Standard Test Method for Detection of Holes in Medical Gloves to determine holes in the gloves.
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves to determine residual powder.
- ASTM D 5712-95 (Re approved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber to determine extractable protein.
The device also underwent Biocompatibility testing based on ISO standards:
- Primary Skin Irritation-ISO 10993-10:2010(E) - Under the condition of study, not an irritant.
- Dermal Sensitization-ISO 10993-10:2010(E) - Under the conditions of the study, not a sensitizer.
- In vitro cytotoxicity ISO10993-5:2009(E) - Under the conditions of the study, cytotoxic.
- Material mediated Pyrogenicity ISO 10993-11:2017(E) / USP 41 - Under the conditions of the study non pyrogenic.
- Acute Systemic Toxicity Test ISO 10993-11:2017(E) - Under the conditions of study the device extracts do not pose a systemic toxicity concern.
The results met the specified acceptance criteria for all tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Length: X-Small 305 mm, Small 306 mm, Medium 307 mm, Large 308 mm, X-Large 310 mm (Min 230 mm for all sizes)
- Width: X-Small 76 mm, Small 85 mm, Medium 96 mm, Large 106 mm, X-Large 116 mm (X-Small 70+/-10 mm, Small 80+/-10mm, Medium 95+/-10 mm, Large 111+/-10 mm, X-Large 115+/-10 mm)
- Thickness: Palm 0.16mm for all sizes, Finger 0.22mm for all sizes (Palm 0.08 mm min, Finger 0.08 mm min for all sizes)
- Tensile Strength (Before ageing): X-Small 22.07 Mpa, Small 22.15 Mpa, Medium 22.22 Mpa, Large 22.30 Mpa, X-Large 22.32 Mpa (18Mpa Min for all sizes)
- Tensile Strength (After ageing): X-Small 18.49 Mpa, Small 18.56 Mpa, Medium 18.67 Mpa, Large 18.74 Mpa, X-Large 18.76 Mpa (14Mpa Min for all sizes)
- Ultimate Elongation (Before ageing): X-Small 858%, Small 869%, Medium 874%, Large 880%, X-Large 882% (650% Min for all sizes)
- Ultimate Elongation (After ageing): X-Small 841%, Small 848%, Medium 854%, Large 860%, X-Large 862% (500% Min for all sizes)
- Stress at 500% Elongation (Before ageing): X-Small 5.1 Mpa, Small 5.1 Mpa, Medium 5.2 Mpa, Large 5.2 Mpa, X-Large 5.2 Mpa (5.5 Mpa Max for all sizes)
- Water Tight: Passes AQL 1.5 (Acceptance Criteria: AQL 2.5)
- Residual Powder Content: 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 (2 Mg/Glove Max)
- Extractable Protein content: 43.65 µg/dm² for all sizes (200 µg/ dm² Max for all sizes)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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.
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.
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 Quality Center for Devices and Radiological Health
Enclosure
2
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) |
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
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 that
Equivalency 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.
4
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
5
| Characteristics | Standards | Device Performance | Comparison | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Predicate | Current | |||||||||||||||||||||
| 510(K) Number | K192329 | K212597 | ||||||||||||||||||||
| Physical Properties- | ||||||||||||||||||||||
| Ultimate Elongation | ASTM | |||||||||||||||||||||
| D3578-2019 | Before Ageing | |||||||||||||||||||||
| Ultimate Elongation > 650% | Before Ageing | |||||||||||||||||||||
| Ultimate Elongation > 650% | ||||||||||||||||||||||
| Size Actual value X-Small 858 Small 869 Medium 874 Large 880 X-Large 882 | Similar | |||||||||||||||||||||
| After Ageing | ||||||||||||||||||||||
| Ultimate Elongation >500% | After Ageing | |||||||||||||||||||||
| Ultimate Elongation > 500% | ||||||||||||||||||||||
| Size Actual value X-Small 841 Small 848 Medium 854 Large 860 X-Large 862 | ||||||||||||||||||||||
| Thickness | ASTM | |||||||||||||||||||||
| D3578-2019 | Palm > 0.08 mm | |||||||||||||||||||||
| Finger > 0.08 mm | Palm > 0.08 mm | |||||||||||||||||||||
| Finger > 0.08 mm | ||||||||||||||||||||||
| Size 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 | Under the | ||||||||||||||||||||
| conditions of the | ||||||||||||||||||||||
| study non pyrogenic | Under the conditions of the | |||||||||||||||||||||
| study, non-pyrogenic | Same |
6
| Characteristics | Standards | Device Performance | Comparison | |
|---|---|---|---|---|
| Predicate | Current | |||
| 510(K) Number | K192329 | K212597 | ||
| 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 | |||
| Water Tight | ||||
| (1000 ml) | ASTM D5151-2019 | Passes AQL-1.5 | Passes AQL-1.5 | Same |
| Intended use | JR MEDIC Blue Latex | |||
| Examination Powder | ||||
| Free Gloves are | ||||
| disposable devices | ||||
| intended for medical | ||||
| purpose that are won | ||||
| on the examiner's | ||||
| hand to prevent | ||||
| contamination | ||||
| between patient and | ||||
| examiner. | 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. | 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 Glove | |||
| Guidance Manual |
- Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non sterile | Non sterile | Same |
| Powder/Powder
free | - | Powder free | Powder free | Same |
| Label and Labeling | FDA Label
requirements | Meets FDA's label
and labeling
requirements | Meets FDA's label
and labeling
requirements | Same |
| Manufacturer(s) | - | JR Engineering &
Medical Technologies
(M) SDN.BHD.
Malaysia | Amazing Rubber Products
Pvt. Ltd. | --- |
G. SUMMARY OF NON-CLINICAL PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D3578-2019 Standard | |||
| Specification for Rubber Examination | |||
| Gloves | To determine the | ||
| length of the gloves | Min 230 mm for all sizes | X-Small 305 mm | |
| Small 306 mm | |||
| Medium 307 mm | |||
| Large 308 mm | |||
| X-Large 310 mm | |||
| ASTM D3578-2019 Standard | |||
| Specification for Rubber Examination | |||
| Gloves | To determine the width | ||
| of the gloves | 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 |
7
| Test Method | Purpose | Acceptance
Criteria | Result | | |
|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| ASTM D3578-2019 Standard
Specification for Rubber
Examination Gloves | To determine the thickness of
the gloves | Palm 0.08 mm min
Finger 0.08 mm min
for all sizes | Size
X-Small
Small
Medium
Large
X-Large | Palm
0.16mm
0.16mm
0.16mm
0.16mm
0.16mm | Finger
0.22mm
0.22mm
0.22mm
0.22mm
0.22mm |
| ASTM D3578-2019
Standard Specification for
Rubber Examination Gloves | To Determine the physical
properties-Tensile strength | Before Ageing
Tensile Strength
18Mpa Min for all
sizes
After Ageing
Tensile Strength
14Mpa Min for all
sizes | Size
X-Small
Small
Medium
Large
X-Large | Before
ageing
22.07 Mpa
22.15 Mpa
22.22 Mpa
22.30 Mpa
22.32 Mpa | After
ageing
18.49 Mpa
18.56 Mpa
18.67 Mpa
18.74 Mpa
18.76 Mpa |
| ASTM D3578-2019
Standard Specification for
Rubber Examination Gloves | To Determine the physical
properties-Ultimate Elongation | Before Ageing
Ultimate Elongation
650% Min for all
sizes
After Ageing
Ultimate Elongation
500% Min for all
sizes | Size
X-Small
Small
Medium
Large
X-Large | Before
ageing
858%
869%
874%
880%
882% | After
ageing
841%
848%
854%
860%
862% |
| | To Determine the physical
properties-stress at 500%
Elongation | Before Ageing
5.5 Mpa Max for all
sizes | Size
X-Small
Small
Medium
Large
X-Large | Before
ageing
5.1 Mpa
5.1 Mpa
5.2 Mpa
5.2 Mpa
5.2 Mpa | NA |
| ASTM D5151-2019 Standard
Test Method for Detection of
Holes in Medical Gloves | To determine the holes in the
gloves | AQL 2.5 | Gloves Passes AQL 1.5 | | |
| ASTM D6124-06
(Reapproved 2017) Standard
Test Method for Residual
Powder on Medical Gloves | To determine the residual
powder in the gloves | 2 Mg/Glove Max | Size
X-Small
Small
Medium
Large
X-Large | Residual Powder
Content
0.21 mg/glove
0.21 mg/glove
0.22 mg/glove
0.22 mg/glove
0.22 mg/glove | |
| ASTM D 5712-95 (Re
approved 2010) Standard Test
Method for the Analysis of
Protein in Natural Rubber | To determine the extractable
protein in the gloves. | 200 µg/ dm² Max for
all sizes | Size
X-Small
Small
Medium
Large
X-Large | Extractable
Protein content
43.65 µg/dm²
43.65 µg/dm²
43.65 µg/dm²
43.65 µg/dm²
43.65 µg/dm² | |
8
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).