(14 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a standard examination glove, with no mention of AI or ML capabilities.
No
Explanation: A patient examination glove is intended to prevent contamination, not to treat or cure a disease or condition.
No
This device, a patient examination glove, is intended to prevent contamination between patient and examiner, and does not perform any diagnostic function.
No
The device is a physical patient examination glove, not a software application. The description focuses on material properties and performance tests related to a physical product.
No, 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 purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and standards met by the glove (latex, powder-free, ASTM standards, FDA water leak test). This aligns with a physical barrier device.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances within those samples.
- Providing diagnostic information.
- Reagents or assays.
The information provided describes a medical device used for personal protection and hygiene during patient examination, which falls under a different regulatory classification than IVD devices.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or finger
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)
Performance data of gloves based on ASTM D3578-01 a22 FDA 1000 ml watertight test.
TEST: Watertight (1000 ml)
ASTM D3578-01aE2 AQL=2.5%: Pass GI
POLYMER COATED POWDER FREE LATEX EXAM GLOVES: GI
AQL: 2.5%
Length (mm):
Size XS: Min 230
S: Min 230
M: Min 230
L: Min 230
XL: Min 230
POLYMER COATED POWDER FREE LATEX EXAM GLOVES: 240 mm minimum for all sizes
Palm width (mm):
Size XS: - , 110 mm
Thickness (mm) (Single Layer):
Finger: Min 0.08, 0.10 minimum
Palm: Min 0.08, 0.10 minimum
Physical Properties:
Before Aging
Tensile Strength (Mpa): Min 14.0, *21.1
Ultimate Elongation (%): Min 650, *817
After Aging
Tensile Strength (Mpa): Min 14.0, *16.7
Ultimate Elongation (%): Min 500, *758
Powder Content: -, Below 2mg / glove
Protein Content: -, Below 50 microgram / gram
The performance data of the glove as showed above meet the ASTM D3578-01a" 8. Standard and FDA's requirement. Powder content is below 2mg per glove, which meet the FDA Requirements.
The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinca 9. Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
Conclusion: The Polymer Coated Powder Free Latex Examination Gloves meet the below specifications: ASTM D3578-01a42 Standard, FDA pinhole requirements, FDA minimum powder residual content.
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.
Not Found
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
The The Career Friders
MA 16 2005
SPI GLOVES SDN. BHD. 5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.com.my
| 1.0 | SMDA 510 (K) SUMMARY | |
|---|---|---|
| 2.0 | Submitter | SPI GLOVES SDN. BHD. |
| 5, Persiaran Greentown 8, | ||
| Greentown Business Centre, | ||
| 30450 Ipoh, Perak, Malaysia. | ||
| Tel | (60 5) 322 3200 | |
| Fax | (60 5) 322 2300 | |
| Name of Contact Person | Ms. CHUN CHOOI FONG | |
| Date of Summary Prepared | February 8, 2005 | |
| 3.0 | Name of Device | |
| Device Name | Polymer Coated Powder Free Latex Examination | |
| Gloves | ||
| Common Name | Exam Glove | |
| Classification Name | Latex Patient Examination Glove |
4.0 Identification of the Legally Marketed Devices
Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01 a 22 and FDA requirements.
5.0 Description of The Device
Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.
6.0 The Intended Use of Glove
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
1
KC 50509
SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.com.my
Summary of Performance Data: רי
Performance data of gloves based on ASTM D3578-01 a22 FDA 1000 ml watertight test.
| POLYMER COATED POWDER FREE LATEX EXAM GLOVES | |||
|---|---|---|---|
| TEST | ASTM D3578-01aE2 | ||
| AQL=2.5% | Pass GI | AQL=2.5% | |
| 1. Watertight (1000 ml) | GI | ||
| 2. Length (mm) | |||
| Size XS | Min 230 | 240 mm minimum for | |
| all sizes | |||
| S | Min 230 | ||
| M | Min 230 | ||
| L | Min 230 | ||
| XL | Min 230 | ||
| 3. Palm width (mm) | |||
| Size XS | - | 110 mm | |
| 4. Thickness (mm) | |||
| (Single Layer) |
Finger | Min 0.08 | 0.10 minimum | |
| Palm | Min 0.08 | 0.10 minimum | |
| 5. Physical Properties
Before Aging
Tensile Strength (Mpa) | Min 14.0 | *21.1 | |
| Ultimate Elongation (%) | Min 650 | *817 | |
| After Aging
Tensile Strength (Mpa) | Min 14.0 | *16.7 | |
| Ultimate Elongation (%) | Min 500 | *758 | |
| 6. Powder Content | - | Below 2mg / glove | |
| 7. Protein Content | - | Below 50 microgram / gram | |
- The average result obtained from Attachment C.
2
Ki 50529
SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.com.my
- The performance data of the glove as showed above meet the ASTM D3578-01a" 8. Standard and FDA's requirement. Powder content is below 2mg per glove, which meet the FDA Requirements.
- The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinca 9. Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
-
- Conclusion
We concluded that the Polymer Coated Powder Free Latex Examination Gloves meet the below specifications:
- ASTM D3578-01a42 Standard -
- FDA pinhole requirements -
- ** FDA minimum powder residual content
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
MAR 16 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Chun Chooi Fong Quality Management System Manager SPI Gloves SND. BHD. 5. Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak, Darul Ridzuan MALAYSIA
Re: K050529
Trade/Device Name: Polymer Coated Powder Free Latex Examination Gloves With Protein Labeling Claim (Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: February 28, 2005 Received: March 2, 2005
Dear Ms. Chooi Fong:
We have reviewed your Scction 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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 - Ms. Chooi Fong
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that 1 DTC issultion on that your device complies with other requirements Incall that I DA has made a dotes and regulations administered by other Federal agencies. of the Act of ally I ederal battle and surface and submitted to: registration 1 our must comply with an are neveling (21 CFR Part 801); good manufacturing practice aller listing (21 CFR Part 807), labeling systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the qualify ijon control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow yourse bogal finding of substantial equivalence of your device to a premiarket notified.com- The PDF results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
: SPI Gloves Sdn. Bhd. Applicant
| 510(K) Number: | K050529 |
|---|---|
| ---------------- | --------- |
: Polymer Coated Powder Free Latex Examination Gloves With Device Name Polymer Coated Fowder Proc Eater Enans 50 micrograms or less of Total Water Extractable Protein per Gram)
Indication For Use:
A patient examination glove is a disposable device intended for medical purposes that is worn A patient examiliation glove is a disposable device mission between patient and examiner.
on the examiner's hands or finger to prevent contamination between patient and exami
Prescription Use: ............................. (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter ..................... (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
.............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheila H. Misselewitz 3/16/05
Control, Dental Devices
K080529