(187 days)
Not Found
Not Found
No
The 510(k) summary describes standard surgical gloves and does not mention any AI or ML capabilities, image processing, or data sets for training/testing.
No
The device is described as surgical gloves intended to protect a surgical wound from contamination, which is a protective barrier function, not a therapeutic intervention.
No
Explanation: The device is a surgical glove, intended to protect a surgical wound from contamination, not to diagnose a medical condition.
No
The device is described as surgical gloves made of natural rubber latex, which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these gloves are for use in medical procedures to protect a surgical wound from contamination and to be worn by operating room personnel. This is a protective barrier function, not a diagnostic one.
- Device Description: The description focuses on the material (natural rubber latex) and protein content, which are relevant to the physical properties and potential for allergic reactions, not diagnostic capabilities.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on biocompatibility, physical properties (meeting ASTM standards), and protein content, all of which relate to the safety and effectiveness of the glove as a barrier device. There are no studies related to diagnostic accuracy or performance.
In vitro diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body to provide information for the diagnosis, monitoring, or screening of diseases or conditions. This description does not align with the purpose of these surgical gloves.
N/A
Intended Use / Indications for Use
Ultraderm Sterile Latex Surgical Gloves with Protein Content Labeling Claim are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive and non-invasive medical procedures requiring sterility They are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
Ultraderm Surgical gloves are formulated using natural rubber latex and contain 50 micrograms or less of total water extractable protein per gram
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room personnel
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)
Test: Primary Skin Irritation; Result: Biocompatability tests were successfully performed on Ultraderm Surgical Gloves with Protein Content Labeling Claim. Gloves do not display any potential for irritation.
Test: Systemic Toxicity; Result: Gloves do not elicit any toxic reactions to acute application.
Test: Intracutaneous Reactivity; Result: Gloves show no reactivity.
Test: Hemocompatibility; Result: Gloves are hemocompatible exhibiting no lysis.
Test: Guinea Pig Maximization; Result: Gloves do not display any potential for irritation.
Test: Ultimate Elongation & Tensile Strength; Result: Gloves meet or exceed requirements for rubber surgical gloves per ASTM D3577-98.
Test: Barrier Defects; Result: Gloves meet or exceed requirements per 21 CFR §800.20, AQL = 2.5.
Test: Data/Test Method; Result: Gloves meet requirements for protein claim of 50 micrograms or less of water extractable protein per gram using ASTM Lowry test method
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.
Ultraderm Sterile Latex Surgical Gloves
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
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
0
Image /page/0/Picture/1 description: The image contains a sequence of handwritten digits and letters. The sequence starts with the letter 'K', followed by the numbers '9911205'. The handwriting style is cursive, and the numbers are connected.
XIV. SUMMARY OF SAFETY AND EFFECTIVENESS
Allegiance
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ULTRADERM STERILE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM
| Manufacturer: | Allegiance Healthcare Sdn. Bhd.
Plot 87, Kampung Jawa
11900 Bayan Lepas
Penang, West Malaysia |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Erica Sethi
Allegiance Healthcare Corporation
1500 Waukegan Road, MP-WM
McGaw Park, IL 60085 |
| Telephone: | (847) 785-3337 |
| Date Summary Prepared: | 3/26/99 |
| Product Trade Name: | Ultraderm Sterile Latex Surgical Gloves with Protein Content
Labeling Claim |
| Common Name: | Surgical Glove |
| Classification: | Glove, Surgeon's |
| Predicate Devices: | Ultraderm Sterile Latex Surgical Gloves |
| Description: | Ultraderm Surgical gloves are formulated using natural rubber latex
and contain 50 micrograms or less of total water extractable protein
per gram |
| Intended Use: | Ultraderm Sterile Latex Surgical Gloves with Protein Content
Labeling Claim are intended for use in environments within hospitals
and other healthcare facilities. The gloves are appropriate for use
during invasive and non-invasive medical procedures requiring sterility
They are intended to be worn by operating room personnel to
protect a surgical wound from contamination. |
1
K991205
Page 2
| Substantial Equivalence: | Ultraderm Sterile Latex Surgical Gloves with Protein Content
Labeling Claim are substantially equivalent to Ultraderm Sterile Latex
Surgical Gloves in that they provide the following characteristics:
- same intended use
- same sizes, configuration, packaging
- both made of natural rubber latex using same formulation
and manufacturing process - same tensile strength and thickness profiles |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Testing: | |
| Test | Result |
| Primary Skin
Irritation | Biocompatability tests were successfully performed on
Ultraderm Surgical Gloves with Protein Content Labeling Claim.
Gloves do not display any potential for irritation. |
| Systemic Toxicity | Gloves do not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity | Gloves show no reactivity. |
| Hemocompatibility | Gloves are hemocompatible exhibiting no lysis. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Ultimate Elongation
& Tensile Strength | Gloves meet or exceed requirements for rubber surgical gloves
per ASTM D3577-98. |
| Barrier Defects | Gloves meet or exceed requirements per 21 CFR
§800.20, AQL = 2.5. |
| Data/Test Method | Gloves meet requirements for protein claim of 50 micrograms or less
of water extractable protein per gram using ASTM Lowry test method |
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 1999
Ms. Erica Sethi Manager, Requlatory Affairs Alleqiance Healthcare Corporation 1500 Waukegan Road McGraw Park, IL 60085
Re : K991205
Trade Name: Ultraderm Sterile Latex Powdered Surqical Gloves With Protein Content Labeling Claim (50 micrograms or less) Regulatory Class: I Product Code: KGO Dated: Auqust 5, 1999 Received: Auqust 9, 1999
Dear Ms. Sethi:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
3
Page 2 - Ms. Sethi
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Susa Runnon
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "K991205". The characters are written in a simple, somewhat rough style, with varying line thickness. The overall impression is that of a quickly written or informal label.
Image /page/4/Picture/1 description: The image shows the word "Allegiance" in a stylized font. To the left of the word is a symbol that resembles a plus sign made up of small dots. The word "Allegiance" is written in a bold, italicized font, with the "A" being larger than the other letters. The overall impression is that of a logo or brand name.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2460
Page 1 of 1
| Applicant: | Allegiance Healthcare Corporation |
|---|---|
| 510(k) Number: | K991205 |
| Device Name: | Ultraderm Sterile Latex Surgical Gloves with Protein Content Labeling Claim (50 micrograms or less) |
| Indications For Use: | These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use X
Olin S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number